Levofloxacin (Page 16 of 16)

PRINCIPAL DISPLAY PANEL

TO OPEN — TEAR AT NOTCH
ONE UNIT
LEVOFLOXACIN INJECTION
in 5% Dextrose
250 mg in 50 mL 5% Dextrose (5 mg/mL)
FOR INTRAVENOUS INFUSION
INFUSE OVER 60 MINUTES
LEAVE BAG IN OVERWRAP UNTIL USE.
PHARMACIST: Dispense the accompanying
Medication Guide to each patient.
Each 50 mL contains a dilute solution equivalent of 250 mg of Levofloxacin, USP
(5 mg/mL) in 5% dextrose. May contain Hydrochloric Acid, NF and/or Sodium
Hydroxide, NF to adjust pH to 3.8-5.8.
USUAL ADULT DOSAGE: See package insert. Recommended storage: at or below
25ºC (77ºF); however, brief exposure up to 40ºC (104ºF) does not adversely affect the
product. Protect from light. Avoid excessive heat and protect from freezing.
Single dose container. 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 container is undamaged. DISCARD UNUSED
PORTION. Must not be used in series connections.
Rx OnlyNDC 0143-9722-01

PRINCIPAL DISPLAY PANEL

TO OPEN — TEAR AT NOTCH
ONE UNIT
LEVOFLOXACIN INJECTION
in 5% Dextrose
500 mg in 100 mL 5% Dextrose (5 mg/mL)
FOR INTRAVENOUS INFUSION
INFUSE OVER 60 MINUTES
LEAVE BAG IN OVERWRAP UNTIL USE.
PHARMACIST: Dispense the accompanying
Medication Guide to each patient.
Each 100 mL contains a dilute solution equivalent of 500 mg of Levofloxacin, USP (5 mg/mL) in
5% dextrose. May contain Hydrochloric Acid, NF and/or Sodium Hydroxide, NF to adjust pH to
3.8-5.8.
USUAL ADULT DOSAGE: See package insert. Recommended storage: at or below 25ºC (77ºF);
however, brief exposure up to 40ºC (104ºF) does not adversely affect the product. Protect from
light. Avoid excessive heat and protect from freezing.
Single dose container. 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 container is undamaged. DISCARD UNUSED PORTION. Must not
be used in series connections.
Rx OnlyNDC 0143-9721-01

PRINCIPAL DISPLAY PANEL

TO OPEN — TEAR AT NOTCH
ONE UNIT
LEVOFLOXACIN INJECTION
in 5% Dextrose
750 mg in 150 mL 5% Dextrose (5 mg/mL)
FOR INTRAVENOUS INFUSION
INFUSE OVER 90 MINUTES
LEAVE BAG IN OVERWRAP UNTIL USE.
PHARMACIST: Dispense the accompanying
Medication Guide to each patient.
Each 150 mL contains a dilute solution equivalent of 750 mg
of Levofloxacin, USP (5 mg/mL) in 5% dextrose. May contain
Hydrochloric Acid, NF and/or Sodium Hydroxide, NF to adjust
pH to 3.8-5.8.
USUAL ADULT DOSAGE: See package insert. Recommended
storage: at or below 25ºC (77ºF); however, brief exposure up to
40ºC (104ºF) does not adversely affect the product. Protect from
light. Avoid excessive heat and protect from freezing.
Single dose container. 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 container is
undamaged. DISCARD UNUSED PORTION. Must not be
used in series connections.
Rx OnlyNDC 0143-9720-01

SERIALIZATION IMAGE

LAYOUT 1

LEVOFLOXACIN levofloxacin injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9722 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVOFLOXACIN (LEVOFLOXACIN ANHYDROUS) LEVOFLOXACIN ANHYDROUS 250 mg in 50 mL

Inactive Ingredients Ingredient Name Strength DEXTROSE MONOHYDRATE 2500 mg in 50 mL HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0143-9722-24 24 BAG in 1 CARTON contains a BAG (0143-9722-01) 1 NDC:0143-9722-01 50 mL in 1 BAG This package is contained within the CARTON (0143-9722-24)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091375 09/16/2011

LEVOFLOXACIN levofloxacin injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9721 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVOFLOXACIN (LEVOFLOXACIN ANHYDROUS) LEVOFLOXACIN ANHYDROUS 500 mg in 100 mL

Inactive Ingredients Ingredient Name Strength DEXTROSE MONOHYDRATE 5000 mg in 100 mL HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0143-9721-24 24 BAG in 1 CARTON contains a BAG (0143-9721-01) 1 NDC:0143-9721-01 100 mL in 1 BAG This package is contained within the CARTON (0143-9721-24)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091375 09/16/2011

LEVOFLOXACIN levofloxacin injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9720 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVOFLOXACIN (LEVOFLOXACIN ANHYDROUS) LEVOFLOXACIN ANHYDROUS 750 mg in 150 mL

Inactive Ingredients Ingredient Name Strength DEXTROSE MONOHYDRATE 7500 mg in 150 mL HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0143-9720-24 24 BAG in 1 CARTON contains a BAG (0143-9720-01) 1 NDC:0143-9720-01 150 mL in 1 BAG This package is contained within the CARTON (0143-9720-24)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091375 09/16/2011

Labeler — Hikma Pharmaceuticals USA Inc. (001230762)

Establishment
Name	Address	ID/FEI	Operations
HIKMA FARMACEUTICA (PORTUGAL), S.A		452742943	ANALYSIS (0143-9722), ANALYSIS (0143-9721), ANALYSIS (0143-9720), LABEL (0143-9722), LABEL (0143-9721), LABEL (0143-9720), MANUFACTURE (0143-9722), MANUFACTURE (0143-9721), MANUFACTURE (0143-9720), PACK (0143-9722), PACK (0143-9721), PACK (0143-9720)

Revised: 03/2019 Hikma Pharmaceuticals USA Inc.