Daunorubicin Hydrochloride (Page 4 of 4)

VIAL LABEL 20 mg/4 mL

Daunorubicin HCl Injection vial label 20 mg/4mL
(click image for full-size original)

Vial Label 20 mg/4 mL

NDC 0143-9551-01

DAUNORUBICIN HCl INJECTION

20 mg/4 mL

(5 mg/mL)

FOR INTRAVENOUS USE ONLY

4 mL SINGLE DOSE VIAL

VIAL LABEL 50 mg/10 mL

NDC 0143-9550-01

DAUNORUBICIN HCl INJECTION

50 mg/10 mL

(5 mg/mL)

FOR INTRAVENOUS USE ONLY

10 mL SINGLE DOSE VIAL

Daunorubicin HCl Injection vial label 50 mg/10 mL
(click image for full-size original)

Vial Label 50 mg/10 mL

SERIALIZATION IMAGE

Representative Carton Serialization Image

Representative Carton Serialization Image

DAUNORUBICIN HYDROCHLORIDE
daunorubicin hydrochloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9551
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DAUNORUBICIN HYDROCHLORIDE (DAUNORUBICIN) DAUNORUBICIN 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 9 mg in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9551-10 10 VIAL in 1 BOX contains a VIAL (0143-9551-01)
1 NDC:0143-9551-01 4 mL in 1 VIAL This package is contained within the BOX (0143-9551-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050731 01/02/2018
DAUNORUBICIN HYDROCHLORIDE
daunorubicin hydrochloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9550
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DAUNORUBICIN HYDROCHLORIDE (DAUNORUBICIN) DAUNORUBICIN 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 9 mg in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9550-01 1 VIAL in 1 CARTON contains a VIAL
1 10 mL in 1 VIAL This package is contained within the CARTON (0143-9550-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050731 01/02/2018
Labeler — Hikma Pharmaceuticals USA Inc. (001230762)

Revised: 12/2019 Hikma Pharmaceuticals USA Inc.

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