SPL Data Element Examples

  --------- ----------------- ----------------------------------------------
  Version   Date of Change    Description of Change

  1         December 2005     Original version

  2         February 2006     Change to translation code for example 4.4
  --------- ----------------- ----------------------------------------------

Table of Contents

[1. Product 2](#product)

[1.1. Describing the product name, code and dosage form
2](#describing-the-product-name-code-and-dosage-form)

[2. Active ingredient 3](#active-ingredient)

[2.1. Describing the strength of an active ingredient
3](#describing-the-strength-of-an-active-ingredient)

[2.2. Describing the strength of an active ingredient powder for oral
suspension
4](#describing-the-strength-of-an-active-ingredient-powder-for-oral-suspension)

[2.3. Inclusion of the Unique Ingredient Identifier (UNII) with the
active ingredient.
5](#inclusion-of-the-unique-ingredient-identifier-unii-with-the-active-ingredient.)

[3. Inactive ingredient 6](#inactive-ingredient)

[3.1. Describing the strength of an inactive ingredient
6](#describing-the-strength-of-an-inactive-ingredient)

[4. Packaging 7](#packaging)

[4.1. Describing one package configuration for one product
7](#describing-one-package-configuration-for-one-product)

[4.2. Describing more than one package configuration for one product
8](#describing-more-than-one-package-configuration-for-one-product)

[4.3. Describing packaging with more than one level of packaging
9](#describing-packaging-with-more-than-one-level-of-packaging)

[4.4. Describing packaging for a combination of two or more products
that have no individual packaging
11](#describing-packaging-for-a-combination-of-two-or-more-products-that-have-no-individual-packaging)

[4.5. Describing packaging for a combination of more than one
individually packaged product
14](#describing-packaging-for-a-combination-of-more-than-one-individually-packaged-product)

[5. Route of Administration 18](#route-of-administration)

[5.1. Describing route of administration
18](#describing-route-of-administration)

[6. Solid Oral Dosage Form Characteristics
19](#solid-oral-dosage-form-characteristics)

[6.1. Describing characteristics of a solid oral dosage form.
19](#describing-characteristics-of-a-solid-oral-dosage-form.)

[7. DEA Schedule 21](#dea-schedule)

[7.1. Describing the DEA schedule of a product
21](#describing-the-dea-schedule-of-a-product)

# Product

## Describing the product name, code and dosage form

Text:

> The product is MiracleDrug (gooddrug) is supplied as tablets.

XML:

> [\<manufacturedMedicine\>]{.mark}
>
> [\<code code=\"0001-0001\"
> codeSystem=\"2.16.840.1.113883.6.69\"/\>]{.mark}
>
> [\<name\>MiracleDrug\</name\>]{.mark}
>
> [\<formCode code=\"C42998\" codeSystem=\"2.16.840.1.113883.3.26.1.1\"
> displayName=\"TABLET\"/\>]{.mark}
>
> [\<asEntityWithGeneric\>]{.mark}
>
> [\<genericMedicine\>]{.mark}
>
> [\<name\>gooddrug\</name\>]{.mark}
>
> [\</genericMedicine\>]{.mark}
>
> [\</asEntityWithGeneric\>]{.mark}

# Active ingredient

## Describing the strength of an active ingredient

Text:

> MiracleDrug Sodium is a tablet containing goodingredient sodium
> equivalent to 500 mg of goodingredient.

XML:

[\<activeIngredient\>]{.mark}

> [\<quantity\>]{.mark}
>
> [\<numerator value=\"500\" unit=\"mg\"\>]{.mark}
>
> [\<translation code=\"C28253\"
> codeSystem=\"2.16.840.1.113883.3.26.1.1\" displayName=\"MILLIGRAM\"
> value=\"500\"/\>]{.mark}
>
> [\</numerator\>]{.mark}
>
> [\<denominator value=\"1\" unit=\"1\"\>]{.mark}
>
> [\<translation code=\"C48542\"
> codeSystem=\"2.16.840.1.113883.3.26.1.1\" displayName=\"TABLET\"
> value=\"1\"/\>]{.mark}
>
> [\</denominator\>]{.mark}
>
> [\</quantity\>]{.mark}
>
> [\<activeIngredientSubstance\>]{.mark}
>
> [\<name\>goodingredient sodium\</name\>]{.mark}
>
> [\<activeMoiety\>]{.mark}
>
> [\<activeMoiety\>]{.mark}
>
> [\<name\>goodingredient\</name\>]{.mark}
>
> [\</activeMoiety\>]{.mark}
>
> [\</activeMoiety\>]{.mark}
>
> [\</activeIngredientSubstance\>]{.mark}

[\</activeIngredient\>]{.mark}

## Describing the strength of an active ingredient powder for oral suspension 

Text:

> MiracleDrug for Oral Suspension is a white powder. When constituted as
> directed, MiracleDrug for Oral Suspension contains 20 mg of gooddrug
> per 5 mL.

XML:

> \<activeIngredient\>
>
> \<quantity\>
>
> \<numerator [value=\"20\" unit=\"mg\"]{.mark}\>
>
> \<translation code=\"**C28253**\"
> codeSystem=\"**2.16.840.1.113883.3.26.1.1**\"
> displayName=\"**MILLIGRAM**\" value=\"**20**\" /\>
>
> ** ** \</numerator\>
>
> \<denominator [value=\"5\" unit=\"mL\"]{.mark}\>
>
> \<translation code=\"**C28254**\"
> codeSystem=\"**2.16.840.1.113883.3.26.1.1**\"
> displayName=\"**MILLILITER**\" value=\"**5**\" /\> ** **
>
> \</denominator\>
>
> ** ** \</quantity\>
>
> \<activeIngredientSubstance\>
>
> ** ** \<name\>**goodingredient sodium**\</name\>
>
> \<activeMoiety\>
>
> \<activeMoiety\>
>
> \<name\>**goodingredient**\</name\>
>
> ** ** \</activeMoiety\>
>
> ** ** \</activeMoiety\>
>
> \</activeIngredientSubstance\>
>
> ** ** \</activeIngredient\>

## Inclusion of the Unique Ingredient Identifier (UNII) with the active ingredient.

Text:

> MiracleDrug Sodium contains goodingredient sodium equivalent to 500 mg
> of goodingredient.

XML:

[\<activeIngredient\>]{.mark}

> [\<quantity\>]{.mark}
>
> [\<numerator value=\"500\" unit=\"mg\"\>]{.mark}
>
> [\<translation code=\"C28253\"
> codeSystem=\"2.16.840.1.113883.3.26.1.1\" displayName=\"MILLIGRAM\"
> value=\"500\"/\>]{.mark}
>
> [\</numerator\>]{.mark}
>
> [\<denominator value=\"1\" unit=\"1\"\>]{.mark}
>
> [\<translation code=\"C48542\"
> codeSystem=\"2.16.840.1.113883.3.26.1.1\" displayName=\"TABLET\"
> value=\"1\"/\>]{.mark}
>
> [\</denominator\>]{.mark}
>
> [\</quantity\>]{.mark}
>
> [\<activeIngredientSubstance\>]{.mark}
>
> [\<code codeSystem=\"2.16.840.1.113883.4.9\" codeSystemName=\"FDA
> SRS\" code=\"xxxxxxxxx\"/\>]{.mark}
>
> [\<name\>good ingredient sodium\</name\>]{.mark}
>
> [\<activeMoiety\>]{.mark}
>
> [\<activeMoiety\>]{.mark}
>
> [\<code codeSystem=\"2.16.840.1.113883.4.9\" codeSystemName=\"FDA
> SRS\" code=\"xxxxxxxxx1\"/\>]{.mark}
>
> [\<name\>good ingredient\</name\>]{.mark}
>
> [\</activeMoiety\>]{.mark}
>
> [\</activeMoiety\>]{.mark}
>
> [\</activeIngredientSubstance\>]{.mark}

[\</activeIngredient\>]{.mark}

# Inactive ingredient

## Describing the strength of an inactive ingredient

Text:

The inactive ingredients include 25 mg of mannitol per 5 mL and sodium
hydroxide to adjust the pH.

XML:

\<inactiveIngredient\>

> \<quantity\>
>
> \<numerator [value=\"25\" unit=\"mg\"]{.mark}\>
>
> \<translation code=\"**C28253**\"
> codeSystem=\"**2.16.840.1.113883.3.26.1.1**\"
> displayName=\"**MILLIGRAM**\" value=\"**25**\" /\>
>
> \</numerator\>
>
> \<denominator [value=\"5\" unit=\"mL\"]{.mark}\>
>
> \<translation code=\"**C28254**\"
> codeSystem=\"**2.16.840.1.113883.3.26.1.1**\"
> displayName=\"**MILLILITER**\" value=\"**5**\" /\>
>
> \</denominator\>
>
> \</quantity\>
>
> \<inactiveIngredientSubstance\>
>
> \<name\>**mannitol**\</name\>
>
> \</inactiveIngredientSubstance\>

\</inactiveIngredient\>

\<inactiveIngredient\>

> \<inactiveIngredientSubstance\>
>
> \<name\>**sodium hydroxide**\</name\>
>
> \</inactiveIngredientSubstance\>

\</inactiveIngredient\>

# Packaging

## Describing one package configuration for one product

Text:

> MiracleDrug for Oral Suspension is a white powder. When constituted as
> directed, MiracleDrug for Oral Suspension contains 20 mg of gooddrug
> per 5 mL. It is available in a 50 mL bottle containing 200 mg of
> gooddrug (NDC 0001-0002-02). \[See example 2.2 for the description of
> the active ingredient\]

XML:

[\<asContent\>]{.mark}

> [\<quantity\>]{.mark}
>
> [\<numerator value=\"50\" unit=\"mL\"\>]{.mark}
>
> [\<translation code=\"C28254\"
> codeSystem=\"2.16.840.1.113883.3.26.1.1\" displayName=\"MILLILITER\"
> value=\"50\"/\>]{.mark}
>
> [\</numerator\>]{.mark}
>
> [\<denominator value="1" unit="1"\>]{.mark}
>
> [\<translation value=\"1\"/\>]{.mark}
>
> [\</denominator\>]{.mark}
>
> [\</quantity\>]{.mark}
>
> [\<containerPackagedMedicine\>]{.mark}
>
> [\<code code=\"0001-0002-02\" codeSystem=\"2.16.840.1.113883.6.69\"
> codeSystemName=\"NDC\"/\>]{.mark}
>
> [\<formCode code=\"C43169\" codeSystem=\"2.16.840.1.113883.3.26.1.1\"
> displayName=\"BOTTLE\"/\>]{.mark}
>
> [\</containerPackagedMedicine\>]{.mark}

[\</asContent\>]{.mark}

## Describing more than one package configuration for one product 

Text:

The product is available in a bottle of 100 tablets (NDC 0001-0001-01)
and a bottle of 30 tablets (NDC 0001-0001-02).

XML:

[\<asContent\>]{.mark}

> [\<quantity\>]{.mark}
>
> [\<numerator value=\"100\" unit=\"1\"\>]{.mark}
>
> [\<translation code=\"C48542\"
> codeSystem=\"2.16.840.1.113883.3.26.1.1\" displayName=\"TABLET\"
> value=\"100\"/\>]{.mark}
>
> [\</numerator\>]{.mark}
>
> [\<denominator value=\"1\" unit=\"1\"\>]{.mark}
>
> [\<translation value=\"1\"/\>]{.mark}
>
> [\</denominator\>]{.mark}
>
> [\</quantity\>]{.mark}
>
> [\<containerPackagedMedicine\>]{.mark}
>
> [\<code code=\"0001-0001-01\" codeSystem=\"2.16.840.1.113883.6.69\"
> codeSystemName=\"NDC\"/\>]{.mark}
>
> [\<formCode code=\"C43169\" codeSystem=\"2.16.840.1.113883.3.26.1.1\"
> displayName=\"BOTTLE\"/\>]{.mark}
>
> [\</containerPackagedMedicine\>]{.mark}

[\</asContent\>]{.mark}

[\<asContent\>]{.mark}

> [\<quantity\>]{.mark}
>
> [\<numerator value=\"30\" unit=\"1\"\>]{.mark}
>
> [\<translation code=\"C48542\"
> codeSystem=\"2.16.840.1.113883.3.26.1.1\" displayName=\"TABLET\"
> value=\"30\"/\>]{.mark}
>
> [\</numerator\>]{.mark}
>
> [\<denominator value=\"1\" unit=\"1\"\>]{.mark}
>
> [\<translation value=\"1\"/\>]{.mark}
>
> [\</denominator\>]{.mark}
>
> [\</quantity\>]{.mark}
>
> [\<containerPackagedMedicine\>]{.mark}
>
> [\<code code=\"0001-0001-02\" codeSystem=\"2.16.840.1.113883.6.69\"
> codeSystemName=\"NDC\"/\>]{.mark}
>
> [\<formCode code=\"C43169\" codeSystem=\"2.16.840.1.113883.3.26.1.1\"
> displayName=\"BOTTLE\"/\>]{.mark}
>
> [\</containerPackagedMedicine\>]{.mark}

[\</asContent\>]{.mark}

## Describing packaging with more than one level of packaging

Text:

MiracleDrug Tablets comes packaged with 5 tablets in a blister pack with
2 blister packs in a box (NDC 0001-0001-04) with 3 boxes in a carton
(NDC 0001-0001-05).

XML:

[\<asContent\>]{.mark}

> [\<quantity\>]{.mark}
>
> [\<numerator value=\"5\" unit=\"1\"\>]{.mark}
>
> [\<translation code=\"C48542\"
> codeSystem=\"2.16.840.1.113883.3.26.1.1\" displayName=\"TABLET\"
> value=\"5\"/\>]{.mark}
>
> [\</numerator\>]{.mark}
>
> [\<denominator value=\"1\" unit=\"1\"\>]{.mark}
>
> [\<translation value=\"1\"/\>]{.mark}
>
> [\</denominator\>]{.mark}
>
> [\</quantity\>]{.mark}
>
> [\<containerPackagedMedicine\>]{.mark}
>
> [\<code/\>]{.mark}
>
> [\<formCode code=\"C43168\" codeSystem=\"2.16.840.1.113883.3.26.1.1\"
> displayName=\"BLISTER PACK\"/\>]{.mark}
>
> [\<asContent\>]{.mark}
>
> [\<quantity\>]{.mark}
>
> [\<numerator value=\"2\" unit=\"1\"\>]{.mark}
>
> [\<translation code=\"C44278\"
> codeSystem=\"2.16.840.1.113883.3.26.1.1\" displayName=\"UNITS\"
> value=\"2\"/\>]{.mark}
>
> [\</numerator\>]{.mark}
>
> [\<denominator value="1" unit="1"\>]{.mark}
>
> [\<translation value=\"1\"/\>]{.mark}
>
> [\</denominator\>]{.mark}
>
> [\</quantity\>]{.mark}
>
> [\<containerPackagedMedicine\>]{.mark}
>
> [\<code code=\"0001-0001-04\" codeSystem=\"2.16.840.1.113883.6.69\"
> codeSystemName=\"NDC\"/\>]{.mark}
>
> [\<formCode code=\"C43178\" codeSystem=\"2.16.840.1.113883.3.26.1.1\"
> displayName=\"BOX\"/\>]{.mark}
>
> [\<asContent\>]{.mark}
>
> [\<quantity\>]{.mark}
>
> [\<numerator value=\"3\" unit=\"1\"\>]{.mark}
>
> [\<translation code=\"C48478\"
> codeSystem=\"2.16.840.1.113883.3.26.1.1\" displayName=\"BOX\"
> value=\"3\"/\>]{.mark}
>
> [\</numerator\>]{.mark}
>
> [\<denominator value=\"1\" unit=\"1\"\>]{.mark}
>
> [\<translation value=\"1\"/\>]{.mark}
>
> [\</denominator\>]{.mark}
>
> [\</quantity\>]{.mark}
>
> [\<containerPackagedMedicine\>]{.mark}
>
> [\<code code=\"0001-0001-05\" codeSystem=\"2.16.840.1.113883.6.69\"
> codeSystemName=\"NDC\"/\>]{.mark}
>
> [\<formCode code=\"C43182\" codeSystem=\"2.16.840.1.113883.3.26.1.1\"
> displayName=\"CARTON\"/\>]{.mark}
>
> [\</containerPackagedMedicine\>]{.mark}
>
> [\</asContent\>]{.mark}
>
> [\</containerPackagedMedicine\>]{.mark}
>
> [\</asContent\>]{.mark}
>
> [\</containerPackagedMedicine\>]{.mark}

[\</asContent\>]{.mark}

## Describing packaging for a combination of two or more products that have no individual packaging

Text:

MiracleDrug Monthly (gooddrug) contains 14 MiracleDrug 10 mg tablets and
14 MiracleDrug 20 mg tablets in a Dialpack (NDC 0001-0003-01).

XML:

[\<manufacturedMedicine\>]{.mark}

> [\<code code=\"0001-0003\" codeSystem=\"2.16.840.1.113883.6.69\"
> codeSystemName=\"NDC\"/\> \<name\>MiracleDrug Monthly\</name\>]{.mark}
>
> [\<formCode code=\"C48504\" codeSystem=\"2.16.840.1.113883.3.26.1.1\"
> displayName=\"KIT\"/\>]{.mark}
>
> [\<asEntityWithGeneric\>]{.mark}
>
> [\<genericMedicine\>]{.mark}
>
> [\<name\> gooddrug\</name\>]{.mark}
>
> [\</genericMedicine\>]{.mark}
>
> [\</asEntityWithGeneric\>]{.mark}
>
> [\<asContent\>]{.mark}
>
> [\<quantity\>]{.mark}
>
> [\<numerator value=\"1\" unit=\"1\"\>]{.mark}
>
> [\<translation code=\"C48504\"
> codeSystem=\"2.16.840.1.113883.3.26.1.1\" displayName=\"KIT\"
> value=\"1\"/\>]{.mark}
>
> [\</numerator\>]{.mark}
>
> [\<denominator value=\"1\" unit=\"1\"\>]{.mark}
>
> [\<translation value=\"1\"/\>]{.mark}
>
> [\</denominator\>]{.mark}
>
> [\</quantity\>]{.mark}
>
> [\<containerPackagedMedicine\>]{.mark}
>
> [\<code code=\"0001-0003-01\" codeSystem=\"2.16.840.1.113883.6.69\"
> codeSystemName=\"NDC\"\> \</code\>]{.mark}
>
> [\<formCode code=\"C43192\" codeSystem=\"2.16.840.1.113883.3.26.1.1\"
> codeSystemName=\"NCI Thesaurus\" displayName=\"DIALPACK\"/\>]{.mark}
>
> [\</containerPackagedMedicine\>]{.mark}
>
> [\</asContent\>]{.mark}
>
> [\<part\>]{.mark}
>
> [\<quantity\>]{.mark}
>
> [\<numerator value=\"14\" unit=\"1\"\>]{.mark}
>
> [\<translation code=\"C48542\"
> codeSystem=\"2.16.840.1.113883.3.26.1.1\" displayName=\"TABLET\"
> value=\"14\"/\>]{.mark}
>
> [\</numerator\>]{.mark}
>
> [\<denominator value=\"1\" unit=\"1\"\>]{.mark}
>
> [\<translation value=\"1\"/\>]{.mark}
>
> [\</denominator\>]{.mark}
>
> [\</quantity\>]{.mark}
>
> [\<partMedicine\>]{.mark}
>
> [\<name\>MiracleDrug 10 mg Tablet\</name\>]{.mark}
>
> [\<formCode code=\"C42998\" codeSystem=\"2.16.840.1.113883.3.26.1.1\"
> codeSystemName=\"NCI Thesaurus\" displayName=\"TABLET\"/\>]{.mark}
>
> [\<activeIngredient\>]{.mark}
>
> [\<quantity\>]{.mark}
>
> [\<numerator value=\"10\" unit=\"mg\"\>]{.mark}
>
> [\<translation code=\"C28253\"
> codeSystem=\"2.16.840.1.113883.3.26.1.1\" codeSystemName=\"NCI
> Thesaurus\" displayName=\"MILLIGRAM\" value=\"10\"/\>]{.mark}
>
> [\</numerator\>]{.mark}
>
> [\<denominator value=\"1\" unit=\"1\"\>]{.mark}
>
> [\<translation]{.mark} code=\"C48542\"
> codeSystem=\"2.16.840.1.113883.3.26.1.1\" displayName=\"TABLET\"
> [value=\"1\"/\>]{.mark}
>
> [\</denominator\>]{.mark}
>
> [\</quantity\>]{.mark}
>
> [\<activeIngredientSubstance\>]{.mark}
>
> [\<name\>gooddrug sodium\</name\>]{.mark}
>
> [\<activeMoiety\>]{.mark}
>
> [\<activeMoiety\>]{.mark}
>
> [\<name\>gooddrug\</name\>]{.mark}
>
> [\</activeMoiety\>]{.mark}
>
> [\</activeMoiety\>]{.mark}
>
> [\</activeIngredientSubstance\>]{.mark}
>
> [\</activeIngredient\>]{.mark}
>
> [\</partMedicine\>]{.mark}
>
> [\</part\>]{.mark}
>
> [\<part\>]{.mark}
>
> [\<quantity\>]{.mark}
>
> [\<numerator value=\"14\" unit=\"1\"\>]{.mark}
>
> [\<translation code=\"C48542\"
> codeSystem=\"2.16.840.1.113883.3.26.1.1\" displayName=\"TABLET\"
> value=\"14\"/\>]{.mark}
>
> [\</numerator\>]{.mark}
>
> [\<denominator value=\"1\" unit=\"1\"\>]{.mark}
>
> [\<translation value=\"1\"/\>]{.mark}
>
> [\</denominator\>]{.mark}
>
> [\</quantity\>]{.mark}
>
> [\<partMedicine\>]{.mark}
>
> [\<name\>MiracleDrug 20 mg Tablet\</name\>]{.mark}
>
> [\<formCode code=\"C42998\" codeSystem=\"2.16.840.1.113883.3.26.1.1\"
> displayName=\"TABLET\"/\>]{.mark}
>
> [\<activeIngredient\>]{.mark}
>
> [\<quantity\>]{.mark}
>
> [\<numerator value=\"20\" unit=\"mg\"\>]{.mark}
>
> [\<translation code=\"C28253\"
> codeSystem=\"2.16.840.1.113883.3.26.1.1\" displayName=\"MILLIGRAM\"
> value=\"20\"/\>]{.mark}
>
> [\</numerator\>]{.mark}
>
> [\<denominator value=\"1\" unit=\"1\"\>]{.mark}
>
> [\<translation]{.mark} code=\"C48542\"
> codeSystem=\"2.16.840.1.113883.3.26.1.1\" displayName=\"TABLET\"
> [value=\"1\"/\>]{.mark}
>
> [\</denominator\>]{.mark}
>
> [\</quantity\>]{.mark}
>
> [\<activeIngredientSubstance\>]{.mark}
>
> [\<name\>gooddrug sodium\</name\>]{.mark}
>
> [\<activeMoiety\>]{.mark}
>
> [\<activeMoiety\>]{.mark}
>
> [\<name\>gooddrug\</name\>]{.mark}
>
> [\</activeMoiety\>]{.mark}
>
> [\</activeMoiety\>]{.mark}
>
> [\</activeIngredientSubstance\>]{.mark}
>
> [\</activeIngredient\>]{.mark}
>
> [\</partMedicine\>]{.mark}
>
> [\</part\>]{.mark}

[\</manufacturedMedicine\>]{.mark}

## Describing packaging for a combination of more than one individually packaged product

Text:

MiracleDrug Combo (gooddrug) is packaged in a carton (NDC 0001-0003-01)
with two parts. One part is MiracleDrug Solution with 50 mg of gooddrug
sodium in 2 mL of solution for injection packaged in a vial with 4 mL
(NDC 0001-0002-01) with a route of administration of IV or IM. The
second part is MiracleDrug Tablets with 25 mg of gooddrug sodium
packaged in a bottle of 30 tablets (NDC 0001-0001-02) with an oral route
of administration.

XML:

\<manufacturedMedicine\>

> \<code code=\"0001-0003\" codeSystem=\"2.16.840.1.113883.6.69\"
> codeSystemName=\"NDC\"/\>
>
> \<name\>MiracleDrug Combo\</name\>
>
> \<formCode code=\"C47916\" codeSystem=\"2.16.840.1.113883.3.26.1.1\"
> codeSystemName=\"NCI Thesaurus\" displayName=\"KIT\"/\>
>
> \<asEntityWithGeneric\>
>
> \<genericMedicine\>
>
> \<name\> gooddrug\</name\>
>
> \</genericMedicine\>
>
> \</asEntityWithGeneric\>
>
> \<asContent\>
>
> \<quantity\>
>
> \<numerator [value=\"1\" unit=\"1\"]{.mark}\>
>
> \<translation code=\"C48504\"
> codeSystem=\"2.16.840.1.113883.3.26.1.1\" displayName=\"KIT\"
> value=\"1\"/\>
>
> \</numerator\>
>
> \<denominator [value=\"1\" unit=\"1\"]{.mark}\>
>
> \<translation value=\"1\"/\>
>
> \</denominator\>
>
> \</quantity\>
>
> \<containerPackagedMedicine\>
>
> \<code code=\"0001-0003-01\" codeSystem=\"2.16.840.1.113883.6.69\"
> codeSystemName=\"NDC\"/\>
>
> \<formCode code=\"C43182\" codeSystem=\"2.16.840.1.113883.3.26.1.1\"
> codeSystemName=\"NCI Thesaurus\" displayName=\"CARTON\"/\>
>
> \</containerPackagedMedicine\>
>
> \</asContent\>
>
> \<part\>
>
> \<quantity\>
>
> \<numerator [value=\"4\" unit=\"mL\"]{.mark}\>
>
> \<translation [code=\"C28254\"
> codeSystem=\"2.16.840.1.113883.3.26.1.1\"
> displayName=\"MILLILITER\"]{.mark} value=\"4\"/\>
>
> \</numerator\>
>
> \<denominator [value=\"1\" unit=\"1\"]{.mark}\>
>
> \<translation value=\"1\"/\>
>
> \</denominator\>
>
> \</quantity\>
>
> \<partMedicine\>
>
> \<code code=\"0001-0002\" codeSystem=\"2.16.840.1.113883.6.69\"
> codeSystemName=\"NDC\"/\>
>
> \<name\>MiracleDrug Solution\</name\>
>
> \<formCode code=\"C42945\" codeSystem=\"2.16.840.1.113883.3.26.1.1\"
> codeSystemName=\"NCI Thesaurus\" displayName=\"INJECTION,
> SOLUTION\"/\>
>
> \<activeIngredient\>
>
> \<quantity\>
>
> \<numerator [value=\"50\" unit=\"mg\"]{.mark}\>
>
> \<translation code=\"C28253\"
> codeSystem=\"2.16.840.1.113883.3.26.1.1\" codeSystemName=\"NCI
> Thesaurus\" displayName=\"MILLIGRAM\" value=\"50\"/\>
>
> \</numerator\>
>
> \<denominator [value=\"2\" unit=\"mL\"]{.mark}\>
>
> \<translation code=\"C28254\"
> codeSystem=\"2.16.840.1.113883.3.26.1.1\" codeSystemName=\"NCI
> Thesaurus\" displayName=\"MILLILITER\" value=\"2\"/\>
>
> \</denominator\>
>
> \</quantity\>
>
> \<activeIngredientSubstance\>
>
> \<name\>gooddrug sodium\</name\>
>
> \<activeMoiety\>
>
> \<activeMoiety\>
>
> \<name\>gooddrug\</name\>
>
> \</activeMoiety\>
>
> \</activeMoiety\>
>
> \</activeIngredientSubstance\>
>
> \</activeIngredient\>
>
> \<asEntityWithGeneric\>
>
> \<genericMedicine\>
>
> \<name\>gooddrug\</name\>
>
> \</genericMedicine\>
>
> \</asEntityWithGeneric\>
>
> \<asContent\>
>
> \<quantity\>
>
> \<numerator [value=\"4\" unit=\"mL\"]{.mark}\>
>
> \<translation code=\"C28254\"
> codeSystem=\"2.16.840.1.113883.3.26.1.1\" codeSystemName=\"NCI
> Thesaurus\" displayName=\"MILLILITER\" value=\"4\"/\>
>
> \</numerator\>
>
> \<denominator [value=\"1\" unit=\"1\"]{.mark}\>
>
> \<translation value=\"1\"/\>
>
> \</denominator\>
>
> \</quantity\>
>
> \<containerPackagedMedicine\>
>
> \<code code=\"0001-0002-01\" codeSystem=\"2.16.840.1.113883.6.69\"
> codeSystemName=\"NDC\"/\>
>
> \<formCode code=\"C43226\" codeSystem=\"2.16.840.1.113883.3.26.1.1\"
> codeSystemName=\"NCI Thesaurus\" displayName=\"VIAL\"/\>
>
> \</containerPackagedMedicine\>
>
> \</asContent\>
>
> \</partMedicine\>
>
> \</part\>
>
> \<part\>
>
> \<quantity\>
>
> \<numerator [value=\"30\" unit=\"1\"]{.mark}\>
>
> \<translation [code=\"C48542\"
> codeSystem=\"2.16.840.1.113883.3.26.1.1\"
> displayName=\"TABLET\"]{.mark} value=\"30\"/\>
>
> \</numerator\>
>
> \<denominator [value=\"1\" unit=\"1\"]{.mark}\>
>
> \<translation value=\"1\"/\>
>
> \</denominator\>
>
> \</quantity\>
>
> \<partMedicine\>
>
> \<code code=\"0001-0001\" codeSystem=\"2.16.840.1.113883.6.69\"/\>
>
> \<name\>MiracleDrug Tablet\</name\>
>
> \<formCode code=\"C42998\" codeSystem=\"2.16.840.1.113883.3.26.1.1\"
> displayName=\"TABLET\"/\>
>
> \<activeIngredient\>
>
> \<quantity\>
>
> \<numerator [value=\"25\" unit=\"mg\"]{.mark}\>
>
> \<translation code=\"C28253\"
> codeSystem=\"2.16.840.1.113883.3.26.1.1\" displayName=\"MILLIGRAM\"
> value=\"25\"/\>
>
> \</numerator\>
>
> \<denominator [value=\"1\" unit=\"1\"]{.mark}\>
>
> \<translation code=\"C48542\"
> codeSystem=\"2.16.840.1.113883.3.26.1.1\" displayName=\"TABLET\"
> value=\"1\"/\>
>
> \</denominator\>
>
> \</quantity\>
>
> \<activeIngredientSubstance\>
>
> \<name\>gooddrug sodium\</name\>
>
> \<activeMoiety\>
>
> \<activeMoiety\>
>
> \<name\>gooddrug\</name\>
>
> \</activeMoiety\>
>
> \</activeMoiety\>
>
> \</activeIngredientSubstance\>
>
> \</activeIngredient\>
>
> \<asEntityWithGeneric\>
>
> \<genericMedicine\>
>
> \<name\>gooddrug\</name\>
>
> \</genericMedicine\>
>
> \</asEntityWithGeneric\>
>
> \<asContent\>
>
> \<quantity\>
>
> \<numerator [value=\"30\" unit=\"1\"]{.mark}\>
>
> \<translation code=\"C48542\"
> codeSystem=\"2.16.840.1.113883.3.26.1.1\" codeSystemName=\"NCI
> Thesaurus\" displayName=\"TABLET\" value=\"30\"/\>
>
> \</numerator\>
>
> \<denominator [value=\"1\" unit=\"1\"]{.mark}\>
>
> \<translation value=\"1\"/\>
>
> \</denominator\>
>
> \</quantity\>
>
> \<containerPackagedMedicine\>
>
> \<code code=\"0001-0001-02\" codeSystem=\"2.16.840.1.113883.6.69\"
> codeSystemName=\"NDC\"/\>
>
> \<formCode code=\"C43169\" codeSystem=\"2.16.840.1.113883.3.26.1.1\"
> codeSystemName=\"NCI Thesaurus\" displayName=\"BOTTLE\"/\>
>
> \</containerPackagedMedicine\>
>
> \</asContent\>
>
> \</partMedicine\>
>
> \</part\>

\</manufacturedMedicine\>

# Route of Administration

## Describing route of administration

Text:

MiracleDrug (gooddrug) can be given either intravenously or
intramuscularly.

XML:

\<consumedIn\>

> \<substanceAdministration\>
>
> \<routeCode code=\"C38276\" codeSystem=\"2.16.840.1.113883.3.26.1.1\"
> codeSystemName=\"NCI Thesaurus\" displayName=\"INTRAVENOUS\"/\>
>
> \</substanceAdministration\>

\</consumedIn\>

\<consumedIn\>

> \<substanceAdministration\>
>
> \<routeCode code=\"C28161\" codeSystem=\"2.16.840.1.113883.3.26.1.1\"
> codeSystemName=\"NCI Thesaurus\" displayName=\"INTRAMUSCULAR\"/\>
>
> \</substanceAdministration\>

\</consumedIn\>

# Solid Oral Dosage Form Characteristics

## Describing characteristics of a solid oral dosage form.

Text:

MiracleDrug is a scored capsule shaped tablet. One side of the tablet is
white to off white and the other side is yellow. Printed on one side is
"Miracle C55". Printed on the other side is 20 mg.

XML:

[\<subjectOf\>]{.mark}

> [\<characteristic classCode=\"OBS\"\>]{.mark}
>
> [\<code code=\"SPLCOLOR\"
> codeSystem=\"2.16.840.1.113883.1.11.19255\"/\>]{.mark}
>
> [\<value code=\"C48325\" codeSystem=\"2.16.840.1.113883.3.26.1.1\"
> displayName=\"WHITE\" xsi:type=\"CE\"\>]{.mark}
>
> [\<originalText\>white to off white\</originalText\>]{.mark}
>
> [\</value\>]{.mark}
>
> [\</characteristic\>]{.mark}

[\</subjectOf\>]{.mark}

[\<subjectOf\>]{.mark}

> [\<characteristic classCode=\"OBS\"\>]{.mark}
>
> [\<code code=\"SPLCOLOR\"
> codeSystem=\"2.16.840.1.113883.1.11.19255\"/\>]{.mark}
>
> [\<value code=\"C48330\" codeSystem=\"2.16.840.1.113883.3.26.1.1\"
> displayName=\"YELLOW\" xsi:type=\"CE\"\>]{.mark}
>
> [\<originalText/\>]{.mark}
>
> [\</value\>]{.mark}
>
> [\</characteristic\>]{.mark}

[\</subjectOf\>]{.mark}

[\<subjectOf\>]{.mark}

> [\<characteristic classCode=\"OBS\"\>]{.mark}
>
> [\<code code=\"SPLSCORE\"
> codeSystem=\"2.16.840.1.113883.1.11.19255\"/\>]{.mark}
>
> [\<value value=\"2\" xsi:type=\"INT\"/\>]{.mark}
>
> [\</characteristic\>]{.mark}

[\</subjectOf\>]{.mark}

[\<subjectOf\>]{.mark}

> [\<characteristic classCode=\"OBS\"\>]{.mark}
>
> [\<code code=\"SPLSHAPE\"
> codeSystem=\"2.16.840.1.113883.1.11.19255\"/\>]{.mark}
>
> [\<value code=\"C48345\" codeSystem=\"2.16.840.1.113883.3.26.1.1\"
> displayName=\"OVAL\" xsi:type=\"CE\"\>]{.mark}
>
> [\<originalText\>capsule shaped\</originalText\>]{.mark}
>
> [\</value\>]{.mark}
>
> [\</characteristic\>]{.mark}

[\</subjectOf\>]{.mark}

[\<subjectOf\>]{.mark}

> [\<characteristic classCode=\"OBS\"\>]{.mark}
>
> [\<code code=\"SPLSIZE\"
> codeSystem=\"2.16.840.1.113883.1.11.19255\"/\>]{.mark}
>
> [\<value unit=\"mm\" value=\"10\" xsi:type=\"PQ\"/\>]{.mark}
>
> [\</characteristic\>]{.mark}

[\</subjectOf\>]{.mark}

[\<subjectOf\>]{.mark}

> [\<characteristic classCode=\"OBS\"\>]{.mark}
>
> [\<code code=\"SPLCOATING\"
> codeSystem=\"2.16.840.1.113883.1.11.19255\"/\>]{.mark}
>
> [\<value value=\"false\" xsi:type=\"BL\"/\>]{.mark}
>
> [\</characteristic\>]{.mark}

[\</subjectOf\>]{.mark}

[\<subjectOf\>]{.mark}

> [\<characteristic classCode=\"OBS\"\>]{.mark}
>
> [\<code code=\"SPLSYMBOL\"
> codeSystem=\"2.16.840.1.113883.1.11.19255\"/\>]{.mark}
>
> [\<value value=\"false\" xsi:type=\"BL\"/\>]{.mark}
>
> [\</characteristic\>]{.mark}

[\</subjectOf\>]{.mark}

[\<subjectOf\>]{.mark}

> [\<characteristic classCode=\"OBS\"\>]{.mark}
>
> [\<code code=\"SPLIMPRINT\"
> codeSystem=\"2.16.840.1.113883.1.11.19255\"/\>]{.mark}
>
> [\<value xsi:type=\"ST\"\>Miracle;C55;20;mg\</value\>]{.mark}
>
> [\</characteristic\>]{.mark}

[\</subjectOf\>]{.mark}

# DEA Schedule

## Describing the DEA schedule of a product

Text:

MiracleDrug is classified as a Schedule II controlled substance.

XML:

[\<subjectOf\>]{.mark}

> [\<policy classCode=\"DEADrugSchedule\"\>]{.mark}
>
> [\<code code=\"C48675\" codeSystem=\"2.16.840.1.112883.3.26.1.1\"
> displayName=\"CII\" /\>]{.mark}
>
> [\</policy\>]{.mark}

[\</subjectOf\>]{.mark}