Levofloxacin labels and packages
Active Ingredient Made in Japan
Finished Product Manufactured by:
Janssen Ortho LLC, Gurabo, Puerto Rico 00778 (Tablets).
Janssen Pharmaceutica N.V., Beerse, Belgium (Oral Solution, Injection Single-Use Vials).
Hospira, Inc., Austin, TX 78728 (Injection Premix).
Manufactured for:
Janssen Pharmaceuticals, Inc., Titusville, NJ 08560.
 Janssen Pharmaceuticals, Inc.
Revised September 2013
PRINCIPAL DISPLAY PANEL - 250 mg Tablet Carton
10 blister strips
10 tablets each
NDC 50458-920-10
Once-a-day
Levaquin tablets
(levofloxacin tablets)
Attention Pharmacist: Dispense the accompanying
Medication Guide to each patient.
250 mg
Store at 15 to 30C (59 to 86F).
Rx only
Package Not Child Resistant
PRINCIPAL DISPLAY PANEL - 500 mg Tablet Bottle Label
50 Tablets
NDC 50458-925-50
Once-a-day
Levaquin tablets
(levofloxacin tablets)
500mg
Attention Pharmacist: Dispense the
accompanying Medication Guide
to each patient.
Active Ingredient Made in Japan
Finished Product Manufactured by:
JOLLC
Gurabo, Puerto Rico 00778
Manufactured for:
Janssen Pharmaceuticals, Inc.
Titusville, NJ 08560
PRINCIPAL DISPLAY PANEL - 750 mg Tablet Carton
10 blister strips
10 tablets each
NDC 50458-930-10
Once-a-day
Levaquin tablets
(levofloxacin tablets)
Attention Pharmacist: Dispense the accompanying
Medication Guide to each patient.
750 mg
Store at 15 to 30C (59 to 86F).
Rx only
Package Not Child Resistant
PRINCIPAL DISPLAY PANEL - 25 mg/mL Oral Solution Carton
NDC 50458-170-01
480 mL
ONCE - A - DAY
Levaquin 
(levofloxacin) Oral Solution
25 mg/mL
Each 1 mL contains 25 mg of levofloxacin
in an aqueous solution.
Attention Pharmacist: Dispense the accom-
panying Medication Guide to each patient.
Dosage: For information concerning use
-f LEVAQUIN (levofloxacin) Oral Solution, 
please see Package Insert.
Bulk package not for retail
dispensing.
Dispense in tight, light-resistant container
as defined in the USP.
Store bottle at 25C (77F); excursions
permitted to 15 - 30C (59 - 86F)
Keep out of reach of children.
Active Ingredient Made in Japan
Finished Product Manufactured by:
Janssen Pharmaceutica, N.V.
Beerse, Belgium
Manufactured for:
Janssen Pharmaceuticals, Inc.
Titusville, NJ 08560
Janssen
Rx only
PRINCIPAL DISPLAY PANEL - 500 mg Injection Carton
20 mL
NDC 50458-164-20
Levaquin injection
(levofloxacin injection)
FOR INTRAVENOUS INFUSION
500 mg levofloxacin
(25 mg/mL)
Attention Pharmacist:
Dispense the accompanying
Medication Guide to each patient.
Store at controlled room
temperature and protect
from light.
ORTHO-McNEILTM 
Division of
Ortho-McNeil-Janssen
Pharmaceuticals, Inc.
Rx only.
Manufactured by:
Janssen Pharmaceutica N.V.
Beerse, Belgium
Manufactured for:
Ortho-McNeil, Division of
Ortho-McNeil-Janssen
Pharmaceuticals, Inc.
Raritan, New Jersey 08869
PRINCIPAL DISPLAY PANEL - 750 mg Injection Carton
30 mL
NDC 50458-165-30
Levaquin injection
(levofloxacin injection)
FOR INTRAVENOUS INFUSION
750 mg levofloxacin
(25 mg/mL)
Attention Pharmacist:
Dispense the accompanying
Medication Guide to each patient.
Store at controlled room
temperature and protect
from light.
Rx only.
ORTHO-McNEILTM 
Division of
Ortho-McNeil-Janssen
Pharmaceuticals, Inc.
Manufactured by:
Janssen Pharmaceutica N.V.
Beerse, Belgium
Manufactured for:
Ortho-McNeil, Division of
Ortho-McNeil-Janssen
Pharmaceuticals, Inc.
Raritan, NJ 08869
PRINCIPAL DISPLAY PANEL - 5 mg/mL Injection 50 mL Bag
NDC 50458-167-01
DIN 02236839
TO OPEN - TEAR AT NOTCH
One Unit
50 mL
LEVAQUIN (levofloxacin in
5% dextrose) Injection 
For Intravenous Infusion
250 mg levofloxacin (5 mg/mL)
INFUSE OVER 60 MINUTES
LEAVE BAG IN OVERWRAP UNTIL USE.
Attention Pharmacist: Dispense the accompanying
Medication Guide to each patient.
Each 50 mL contains a dilute solution equivalent of 250 mg of levofloxacin (5 mg/mL) in
5% dextrose. May contain Hydrochloric Acid, NF and/or Sodium Hydroxide, NF for pH
adjustment. pH range 3.8 - 5.8.
Usual Adult Dosage: See Insert. Recommended storage: At or below 25C (77F);
however, brief exposure up to 40C (104F) does not adversely affect the product. Protect from
light. Avoid excessive heat and protect from freezing.
Single-use container. Any unused portion should be discarded. Must not be used in series
connection. Additives should not be added or infused through the same intravenous line. The
-verwrap is a moisture barrier. Do not remove unit from overwrap until ready to use. Use unit
promptly when pouch is open. After removing the overwrap, check for minute leaks by
squeezing container firmly. If leaks are found, discard unit as sterility may be impaired. Use only
if solution is clear and the container is undamaged.
Rx only
Active Ingredient Made in Japan
Finished Product Manufactured by: Hospira, Inc., Austin, TX 78728
Manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ 08560
 Janssen Pharmaceuticals, Inc. 2011
Revised June 2011
WR-0406
PRINCIPAL DISPLAY PANEL - 5 mg/mL Injection 100 mL Bag
Pr
100 mL
NDC 50458-168-01
DIN 02236839
LEVAQUIN (levofloxacin in
5% dextrose) Injection 
FOR INTRAVENOUS INFUSION - 500 mg levofloxacin (5 mg/mL)
For the US: Attention Pharmacist: Dispense the
accompanying Medication Guide to each patient.
For Canada: Pharmacist: Dispense with consumer information.
USE IMMEDIATELY ONCE REMOVED FROM
THE OVERWRAP. INFUSE OVER 60 MINUTES.
No further dilution is necessary. Each 100 mL
contains a dilute solution equivalent of 500 mg of
levofloxacin (5 mg/mL) in 5% dextrose. May contain
Hydrochloric Acid, NF and/or Sodium Hydroxide, NF
to adjust pH to 3.85.8. Additives should not be added
-r infused simultaneously through the same intrave-
nous line. Single-use container. Any unused
portion should be discarded. Usual Adult Dosage: 
See Insert. Sterile (sterile), nonpyrogenic. Use
-nly if solution is clear and container is undamaged.
Must not be used in series connection.
Active Ingredient Made in Japan
Finished Product Manufactured by: Hospira, Inc., Austin, TX 78728
Manufactured for: Janssen Pharmaceuticals,Inc. Titusville,
NJ 08560 and Janssen Inc., Toronto, Canada M3C 1L9
Rx only
IM-2139
Rev. 6/11
500 mg
 Janssen 2011
PRINCIPAL DISPLAY PANEL - 5 mg/mL Injection 150 mL Bag Label
TO OPEN - TEAR AT NOTCH
NDC 50458-166-01
DIN 02236839
One Unit
150 mL
LEVAQUIN (levofloxacin in
5% dextrose) Injection 
For Intravenous Infusion
750 mg levofloxacin (5 mg/mL)
INFUSE OVER 90 MINUTES
LEAVE BAG IN OVERWRAP UNTIL USE.
Attention Pharmacist: Dispense the accompanying
Medication Guide to each patient.
Each 150 mL contains a dilute solution equivalent of 750 mg of levofloxacin (5 mg/mL) in 5% dextrose.
May contain Hydrochloric Acid, NF and/or Sodium Hydroxide, NF for pH adjustment. pH range 3.8 - 5.8.
Usual Adult Dosage: See Insert. Recommended storage: At or below 25C (77F); however, brief
exposure up to 40C (104F) does not adversely affect the product. Protect from light. Avoid excessive
heat and protect from freezing.
Single-use container. Any unused portion should be discarded. Must not be used in series connection.
Additives should not be added or infused through the same intravenous line. The overwrap is a moisture
barrier. Do not remove unit from overwrap until ready to use. Use unit promptly when pouch is open.
After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found,
discard unit as sterility may be impaired. Use only if solution is clear and the container is undamaged.
Rx only
Active Ingredient Made in Japan
Finished Product Manufactured by: Hospira, Inc., Austin, TX 78728
Manufactured for:
Janssen Pharmaceuticals, Inc. Titusville, NJ 08560
 Janssen Pharmaceuticals, Inc. 2011
Revised June 2011
WR-0408