Form 8947: Report of Branded Prescription Drug Information

▶ Information about Form 8947 and its instructions is at www.irs.gov/form8947.

Read the instructions before you complete Form 8947. OMB No. 1545-2192

(Rev. October 2012)

Department of the Treasury — Internal Revenue Service

Information report for 

sales year: 

2011

Item A: Check one 

1 First time Filer (Complete this page and page 6; attach Schedule A) . . . . . . . . . . . . . . . .

2 Subsequent Year Filer with Changes (Complete this page and page 6; attach Schedules B, C, and D as needed) . . . . . .

3 Subsequent Year Filer with No Changes and Reporting Rebates (Complete this page and page 6; attach Schedule D) . . . .

4 Subsequent Year Filer with No Changes and Not Reporting Rebates (Complete this page and page 6) . . . . . . . .

Item B: Check one (see instructions)

1 Single-person covered entity 

Designated entities:

2a Common parent of an 

affiliated group . . .

2b Other designated entity .

Entity name

Address (number and street). If you have a P.O. box, see instructions. 

City, town or post office, state, and ZIP code. If you have a foreign address, see instructions. 

Employer identification number (EIN). 

Part I Controlled Group Members

If you checked Item B, box 2a or 2b: Beginning with the name of the designated entity, list the information for all 

members of the controlled group who, as of the end of the day on December 31, 2011, are manufacturers or importers 

with gross receipts from the sale of branded prescription drugs to specified government programs (or sales due to 

coverage under the programs).

Check if the entity 

was not listed on 

your report for 

sales year 2010

(a) 

Name of entity

(b) 

Address of entity

(c) 

Employer 

identification no.

For Paperwork Reduction Act Notice, see instructions. Cat. No. 37765S Form 8947 (Rev. 10-2012)
Form 8947 (Rev. 10-2012) Page 2

Schedule A Branded Prescription Drug Information – First Time Filers Only (see instructions)

Entity name

Employer identification number (EIN). 

If you have more National Drug Codes (NDCs) to report than can be shown on this 

page, complete and attach as many Schedules A as you need to list them all, 

numbering each page (for example, Page A1 of A5). Page of 

(a) 

Controlled group member 

EIN

(b) 

NDC

(c) 

Medicaid state supplemental 

rebate amount, if applicable 

(if none, enter -0-) 

(d) 

Latest tax year section 

45C orphan drug credit 

allowed, if applicable 

(yyyy) 

(e) 

Name of section 45C orphan drug, if applicable

(f) 

Date of FDA approval 

for non-orphan drug marketing, 

if applicable 

(mmddyyyy) 

$ .

$ .

$ .

$ .

$ .

$ .

$ .

$ .

$ .

$ .

$ .

Form 8947 (Rev. 10-2012)
Form 8947 (Rev. 10-2012) Page 3

Schedule B Branded Prescription Drug Information NDC Additions and Deletions (see instructions)

Caution. Use Schedule B only for additions and deletions of National Drug Codes (NDCs) at the covered entity level. Do not report the movement of NDCs between members of 

the controlled group. 

Entity name

Employer identification number (EIN). 

If you have more NDC additions and deletions to report than can be shown on this 

page, complete and attach as many Schedules B as you need to list them all, 

numbering each page (for example, Page B1 of B5). Page of 

Section I Additions

(a) 

Controlled group member 

EIN

(b) 

NDC additions

(c) 

Medicaid state supplemental 

rebate amount, if applicable 

(if none, enter -0-) 

(d) 

Latest tax year section 

45C orphan drug credit 

allowed, if applicable 

(yyyy) 

(e) 

Name of section 45C orphan drug, if applicable

(f) 

Date of FDA approval 

for non-orphan drug marketing, 

if applicable 

(mmddyyyy) 

$ .

$ .

$ .

$ .

$ .

$ .

$ .

$ .

Section II Deletions

Enter the NDC of any 

branded prescription drug 

you listed on your report for 

sales year 2010 but is no 

longer applicable (see 

instructions).

NDC NDC NDC NDC NDC

NDC NDC NDC NDC NDC

Form 8947 (Rev. 10-2012)
Form 8947 (Rev. 10-2012) Page 4

Schedule C Branded Prescription Drug Information Orphan Drug Changes—Previously Reported NDCs (do not include National Drug Codes (NDCs) or 

orphan drug information reported on Schedule B - see instructions)

Entity name

Employer identification number (EIN). 

If you have more orphan drug changes to report than can be shown on this page, 

complete and attach as many Schedules C as you need to list them all, numbering 

each page (for example, Page C1 of C5). Page of 

(a) 

Controlled group member 

EIN

(b) 

NDC

(c) 

Latest tax year section 

45C orphan drug credit 

allowed, if applicable 

(yyyy) 

(d) 

Name of section 45C orphan drug, if applicable

(e) 

Date of FDA approval 

for non-orphan drug marketing, 

if applicable 

(mmddyyyy) 

Form 8947 (Rev. 10-2012)
Form 8947 (Rev. 10-2012) Page 5

Schedule D Branded Prescription Drug Medicaid State Supplemental Rebates—Previously Reported NDCs (do not include National Drug Codes (NDCs) 

or rebate information reported on Schedule B) 

Entity name

Employer identification number (EIN). 

If you have more rebate information to report than can be shown on this page, 

complete and attach as many Schedules D as you need to list them all, numbering 

each page (for example, Page D1 of D5). Page of 

(a) 

NDC

(b) 

Medicaid state supplemental 

rebate amount, if applicable 

$ .

$ .

$ .

$ .

$ .

$ .

$ .

$ .

$ .

$ .

$ .

$ .

(a) 

NDC

(b) 

Medicaid state supplemental 

rebate amount, if applicable 

$ .

$ .

$ .

$ .

$ .

$ .

$ .

$ .

$ .

$ .

$ .

$ .

(a) 

NDC

(b) 

Medicaid state supplemental 

rebate amount, if applicable 

$ .

$ .

$ .

$ .

$ .

$ .

$ .

$ .

$ .

$ .

$ .

$ .

Form 8947 (Rev. 10-2012)
Form 8947 (Rev. 10-2012) Page 6

Schedule E Summary of Form 8947

Entity name

Employer identification number (EIN). 

1 Total number of controlled group members, including the designated entity, from page 1, Part I . . . .

2 Total National Drug Codes (NDCs) from Schedule(s) A, column (b) . . . . . . . . . . . . . .

3 Total Medicaid state supplemental rebate amounts from Schedule(s) A, column (c) . . . . . . . .

4 Total NDC additions from Schedule(s) B, Section I, column (b) . . . . . . . . . . . . . . .

5 Total Medicaid state supplemental rebate amounts from Schedule(s) B, Section I, column (c) . . . . .

6 Total NDC deletions from Schedule(s) B, Section II . . . . . . . . . . . . . . . . . . .

7 Total NDCs from Schedule(s) C, column (b) . . . . . . . . . . . . . . . . . . . . .

8 Total NDCs from Schedule(s) D, column (a) . . . . . . . . . . . . . . . . . . . . . .

9 Total Medicaid State supplemental rebate amounts from Schedule(s) D, column (b) . . . . . . . .

Part II Signature of Official Signing On Behalf of the Covered Entity (Single-Member, Common Parent of an 

Affiliated Group, or Other Designated Entity) and Consent by the Common Parent or Designated Entity 

(if applicable)

Under penalties of perjury, I declare that I have examined this report, including accompanying statements, and, to the best of my 

knowledge and belief, it is true, correct, and complete. 

[If you checked Item B, box 2a or 2b, on page 1] I also declare that I identified myself as the common parent of an affiliated group or 

other designated entity (as per the instructions). I understand that the designated entity will receive IRS communications relating to 

the fee imposed by section 9008 of the Act and is to pay this fee to the IRS on behalf of the controlled group. Each entity that is a 

member of the controlled group is jointly and severally liable for this fee. I further declare that each entity in the controlled group 

identified on this report consents to the choice of the designated entity indicated on this report.

Sign 

Here

▲

Signature of official Date Title

Print name of signing official Daytime telephone number

Alternate Contact Person Designee (see instructions)

Do you want to designate an employee to discuss this report with the IRS?

Yes, complete below. No

Designee's name Title

Phone

Where To File

Send Form 8947 to: Internal Revenue Service 

1973 Rulon White Boulevard 

Mail Stop 4916 

Ogden, UT 84404

Send the forms in a flat mailing (not folded). Do not staple, tear, or tape any of these forms. If 

you are sending a large number of forms in conveniently sized packages, write your name on 

each package and number the packages consecutively. United States postal regulations 

require forms and packages to be sent by First-Class Mail. However, you may use private 

delivery services such as DHL, Federal Express (FedEx), and United Parcel Service (UPS).

Form 8947 (Rev. 10-2012)
Form 8947 (Rev. 10-2012) Page 7

Section references are to the Internal Revenue Code unless otherwise 

noted.

Future developments. For the latest information about developments 

related to Form 8947 and its instructions, such as legislation enacted 

after they were published, go to www.irs.gov/form8947.

What's New 

If you want to designate your employee to discuss your report with the 

IRS, check the "Yes" box on page 6, under Alternate Contact Person 

Designee. Also, enter the designee's name, title, and phone number. 

If you check the "Yes" box, you are authorizing the IRS to call the 

designee to answer any questions that may arise and the designee to 

call the IRS with any questions related to the administration of the 2013 

branded prescription drug fee year. You are also authorizing the 

designee to:

• Receive copies of IRS letters upon request,

• Respond to IRS letters, and 

• Receive and provide information regarding the status of a payment 

or an amount due back to you. 

General Instructions

Purpose of Form 

Use Form 8947 to report the following information for branded 

prescription drugs sold by covered entities to specified government 

programs (or sales due to coverage under the programs) during sales 

year 2011.

• National Drug Codes (NDCs).

• Medicaid state supplemental rebate information.

• Section 45C orphan drug information.

• Designated entity and controlled group members information, if 

applicable.

The IRS will use the information you submit on Form 8947 to calculate 

the annual fee for branded prescription drug sales ("the fee"). The fee is 

imposed by section 9008 of Public Law 111-148 (Patient Protection and 

Affordable Care Act), as amended by Public Law 111-152 (Health Care 

and Education Reconciliation Act of 2010) (the “Act”).

For more information, see Definitions and Item B. Covered Entity 

Information below. Also, see Temporary Regulations sections 51.1T 

through 51.12T, and section 51.6302-1T. 

Who Files

Generally, each manufacturer or importer of branded prescription drugs 

with sales to specified government programs (or sales due to coverage 

under the programs) may submit Form 8947. Each entity that is treated 

as a single covered entity is requested to file one Form 8947, providing 

all requested information for each such manufacturing and reporting 

entity, as described in these instructions. 

Schedules A, B, C, D, and E. All filers must complete page 1 and page 

6, which includes Schedule E, Summary of Form 8947, and Part II, 

Signature of Official Signing On Behalf of the Covered Entity (SingleMember, Common Parent of an Affiliated Group, or Other Designated 

Entity) and Consent by the Common Parent or Designated Entity (if 

applicable).

First time filers must also attach Schedule A, Branded Prescription 

Drug Information—First Time Filers Only.

Subsequent year filers with changes to report must attach Schedule 

B, Branded Prescription Drug Information NDC Additions and Deletions, 

or Schedule C, Branded Prescription Drug Information Orphan Drug 

Changes—Previously Reported NDCs, or both. 

Subsequent year filers reporting Medicaid state supplemental rebates 

for sales year 2011 drug sales must attach Schedule D, Branded 

Prescription Drug Medicaid State Supplemental Rebates—Previously 

Reported NDCs, to report NDCs and their Medicaid state supplemental 

rebates. See Completing Pages 1 and 6, and the Correct Schedule(s) 

below.

When To File

File Form 8947 by December 17, 2012, to report sales year 2011 

information.

Definitions 

For the definitions of covered entity, single-person covered entity, and 

designated entity, see Item B. Covered Entity Information under Specific 

Instructions.

Completing Pages 1 and 6, and the Correct Schedule(s)

First time filer 

(check Item A, box 1)

Subsequent year filer with 

changes 

(check Item A, box 2)

Subsequent year filer with no 

changes, reporting rebates 

(check Item A, box 3)

Subsequent year filer with no 

changes, not reporting rebates 

(check Item A, box 4)

Page 1 Yes Yes Yes Yes

Schedule A Yes No No No

Schedule B No

Yes, if NDC additions or 

deletions (1), (2), (3) No No

Schedule C No Yes, if orphan drug changes (1), (3) No No

Schedule D No Yes, if reporting rebates (1), (3) Yes No

Schedule E

Schedule E, Line 1

Yes, if Item B, box 2a or 2b, 

checked

Yes, if Item B, box 2a or 2b, 

checked

Yes, if Item B, box 2a or 2b, 

checked

Yes, if Item B, box 2a or 2b, 

checked

Schedule E, Line 2 Yes No No No

Schedule E, Line 3 Yes No No No

Schedule E, Line 4 No Yes, if Schedule B attached No No

Schedule E, Line 5 No Yes, if Schedule B attached No No

Schedule E, Line 6 No Yes, if Schedule B attached No No

Schedule E, Line 7 No Yes, if Schedule C attached No No

Schedule E, Line 8 No Yes, if Schedule D attached Yes No

Schedule E, Line 9 No Yes, if Schedule D attached Yes No

Part II Yes Yes Yes Yes

(1) NDCs reported on Schedule B cannot be shown on Schedules C or D.

(2) On Schedule B, Section I, report as additions only NDCs that were not associated with the covered entity for the previous sales year.

(3) On Schedule B, Section II: Schedule C; or Schedule D, report only NDCs that were associated with the covered entity for the previous sales year.
Form 8947 (Rev. 10-2012) Page 8

Branded prescription drug sales. Branded prescription drug sales are 

sales of branded prescription drugs made to specified government 

programs (or sales due to coverage under the programs). A branded 

prescription drug is any prescription drug for which an application was 

submitted under section 505(b) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 355(b)), or any biological product the license 

for which was submitted under section 351(a) of the Public Health 

Service Act (42 U.S.C. 262(a)). A prescription drug is any drug that is 

subject to section 503(b) of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 353(b)).

Branded prescription drug sales do not include sales of section 45C 

orphan drugs (defined below).

Specified government programs. Specified government programs 

under the Act are: 

• The Medicare Part D program under part D of title XVIII of the Social 

Security Act;

• The Medicare Part B program under part B of title XVIII of the Social 

Security Act; 

• The Medicaid program under title XIX of the Social Security Act; 

• Any program under which branded prescription drugs are procured 

by the Department of Veterans Affairs;

• Any program under which branded prescription drugs are procured 

by the Department of Defense; and

• The TRICARE retail pharmacy program under section 1074g of title 

10, United States Code. 

Section 45C orphan drugs. Generally, branded prescription drug sales 

do not include sales of an orphan drug if any person claimed (and was 

allowed) a section 45C tax credit for the orphan drug on a return or 

claim for refund for any taxable year, and there has not been a final 

assessment or a court disallowance of the full section 45C credit taken 

for the drug.

Non-orphan drug marketing. However, a branded prescription drug is 

not treated as an orphan drug after December 31 of the year in which 

the drug or biological product was approved by the Food and Drug 

Administration (FDA) for non-orphan drug marketing, regardless of 

whether a section 45C credit was allowed for an orphan drug either 

before or after the non-orphan drug designation. Non-orphan drug 

marketing is marketing for any indication other than the treatment of the 

rare disease or condition for which the section 45C tax credit was 

allowed.

Specific Instructions

Item B. Covered Entity Information

Covered entity. A covered entity is any manufacturer or importer with 

gross receipts from branded prescription drug sales. A manufacturer or 

importer is the person identified in the Labeler Code of the NDC for the 

branded prescription drug. The NDC is an identifier assigned by the FDA 

to a branded prescription drug, as well as other drugs. The Labeler 

Code is the first five numeric characters of the NDC, or the first six 

numeric characters when the available five-character code 

combinations are exhausted.

For purposes of the Act, all persons treated as a single employer 

under sections 52(a), 52(b), 414(m), or 414(o) will be treated as one 

covered entity (an Act section 9008(d)(2) controlled group). A covered 

entity is either a single-person covered entity or a member of a 

controlled group. In applying the single employer rules, a foreign entity 

subject to tax under section 881 is included within a controlled group 

under section 52(a) or 52(b). A covered entity is treated as being a 

member of a controlled group if it is a member of the group at the end of 

the day on December 31, 2011. Also, a controlled group that is an 

affiliated group that filed a consolidated federal tax return for tax year 

2011 (“affiliated group”) will be treated as one covered entity. 

Box 1. Check box 1 if you are a single-person covered entity. You must 

sign Part II on page 6.

Designated entity. Generally, the designated entity is one of the 

following.

• The common parent of an affiliated group.

• The member chosen to be the designated entity by the members of a 

controlled group that is not an affiliated group. If a controlled group 

does not select a designated entity, the IRS will select a member of 

the controlled group as the designated entity for the controlled group. 

The designated entity is responsible for the following for the group.

• Filing Form 8947,

• Receiving IRS communications about the fee,

• Filing any necessary error report (as described in Temporary 

Regulations section 51.7T), and

• Paying the fee to the IRS.

Box 2a. Check box 2a if you are a common parent of an affiliated group. 

Also complete Part I, Controlled Group Members, giving the name, 

address, and EIN of only those members of the controlled group who, 

as of the end of the day on December 31, 2011, are manufacturers or 

importers with gross receipts from the sale of branded prescription 

drugs to specified government programs (or sales due to coverage 

under the program), listing the designated entity's name first. You must 

also sign Part II on page 6.

Box 2b. Check box 2b if you are the designated entity for a covered 

entity that is not an affiliated group. Also complete Part I, Controlled 

Group Members, giving the name, address, and EIN of only those 

members of the controlled group who, as of the end of the day on 

December 31, 2011, are manufacturers or importers with gross receipts 

from the sale of branded prescription drugs to specified government 

programs (or sales due to coverage under the program), listing the 

designated entity's name first. You must also sign Part II on page 6.

Name and Address

Entity name. If you checked box 1, enter the name of the single-person 

covered entity. If you checked box 2a or 2b, enter the name of the 

designated entity.

P.O. box. Enter your box number only if your post office does not 

deliver mail to your street address.

Foreign Address. Enter the information in the following order: city, 

province or state, and country. Follow the country's practice for entering 

the postal code. In some countries the postal code may come before 

the city or town name. Enter the full name of the country using 

uppercase letters in English.

Third Party. If you receive your mail in care of a third party (such as an 

accountant or an attorney), enter on the street address line “C/O” 

followed by the third party's name and street address or P.O. box. 

Schedule A. Branded Prescription Drug Information – 

First Time Filers Only

If you filed Form 8947 for sales year 2010, do not use Schedule A for the 

2011 sales year. If you checked Item A, box 1, use Schedule A to report 

the following.

Controlled group member EIN. Enter the same EIN for each member 

that was shown in Part I, column (c).

NDC. Enter the 11-digit NDC (omitting hyphens) for any branded 

prescription drug sold to any specified government program (or sold 

due to coverage under the programs) during 2011.

Medicaid state supplemental rebate amount. Enter the Medicaid 

state supplemental rebates for each NDC paid by the covered entity for 

sales under Medicaid in sales year 2011. For this purpose, enter 

Medicaid state supplemental rebates invoiced by states and paid by the 

covered entity for drugs in sales year 2011 and paid before you file Form 

8947. 
Form 8947 (Rev. 10-2012) Page 9

Latest tax year section 45C orphan drug credit allowed. For the drug 

listed, enter the latest tax year that the section 45C orphan drug credit 

was allowed. The section 45C credit is considered to be allowed if any 

entity claimed the credit even if that entity was not part of the covered 

entity at the time the credit was claimed. Use the format yyyy. Fiscal 

year filers must show the tax year according to the tax year's beginning.

Name of Section 45C Orphan drug. Enter the generic or trade name 

shown on FDA Form 3671, if applicable.

Date of FDA approval for non-orphan drug marketing. Enter the date 

of FDA approval for non-orphan drug marketing, if applicable. Use the 

format mmddyyyy.

Schedule B. Branded Prescription Drug Information 

NDC Additions and Deletions

If you filed Form 8947 for sales year 2010, use Schedule B (check Item 

A, box 2) to report the following for sales year 2011. 

• NDCs that you did not report on your Form 8947 for sales year 2010 

(additions), and

• NDCs that are no longer in the covered entity (deletions). An NDC is no 

longer in the covered entity if you reported it on your Form 8947 for 

sales year 2010 and it ceases to be described in the definition of 

branded prescription drugs for the covered entity's 2011 sales year 

(see Branded Prescription Drugs under Definitions above).

Do not report the movement of NDCs between members of the 

controlled group.

Schedule C. Branded Prescription Drug Information 

Orphan Drug Changes—Previously Reported NDCs

If you filed Form 8947 for sales year 2010, use Schedule C (check Item 

A, box 2) to report changes in orphan drug information for previously 

reported NDCs. Do not include NDCs or orphan drug information 

reported on the Schedule B attached to this report. 

Schedule D. Branded Prescription Drug Medicaid 

State Supplemental Rebates— Previously Reported 

NDCs

If you filed Form 8947 for sales year 2010, use Schedule D (check Item 

A, box 2 or box 3, as applicable) to report Medicaid state supplemental 

rebates paid by the covered entity for sales under Medicaid occurring in 

sales year 2011. Enter rebates only for NDCs which you reported when 

you filed Form 8947 for sales year 2010. For this purpose, enter 

Medicaid state supplemental rebates invoiced by states and paid by the 

covered entity for drugs in sales year 2011 and paid before you file Form 

8947. Do not include NDCs or rebate information reported on the 

Schedule B attached to this report.

Schedule E. Summary of Form 8947

Use Schedule E to report the total number of controlled group 

members, including the designated entity, shown on page 1, Part I, and 

the totals from each of the other schedules attached to this report.

Paperwork Reduction Act Notice. We ask for the information on Form 

8947 to carry out the Internal Revenue laws of the United States. We 

need it to ensure that you are complying with these laws and to allow us 

to figure and collect the right amount of fees. You are not required to file 

Form 8947. If you do not file Form 8947, we will calculate your branded 

prescription drug fee based on information reported on previously filed 

Forms 8947 (if any), NDC information maintained by the FDA, sales and 

rebate information reported by the Agencies, and orphan drug 

information maintained by the IRS.

You are not required to provide the information requested on a form 

that is subject to the Paperwork Reduction Act unless the form displays 

a valid OMB control number. Books or records relating to a form or its 

instructions must be retained as long as their contents may become 

material in the administration of any Internal Revenue law. Generally, 

the information you report on this form is confidential, as required by 

section 6103. 

The time needed to complete and file Form 8947 will vary depending 

on individual circumstances. The estimated average time is: 

Recordkeeping . . . . . . . . . . . . 7 hrs., 24 min.

Preparing, copying, assembling, 

and sending the form . . . . . . . . . . . . 51 min. 

Learning about the law or the form . . . . . . . . 42 min. 

If you have comments concerning the accuracy of these time 

estimates or suggestions for making Form 8947 simpler, we would be 

happy to hear from you. You can email us at taxforms@irs.gov or write 

to us at: 

Internal Revenue Service 

Tax Products Coordinating Committee 

SE:W:CAR:MP:T:I 

1111 Constitution Ave. NW, IR-6526 

Washington, DC 20224

Do not send Form 8947 to this address. Instead, see Where To File on 

page 6.