Doxorubicin Hydrochloride (Page 7 of 7)

Package/Label Display Panel

NDC 0143-9084 -01 Rx only
DOXOrubicin
HCl Injection, USP
10 mg per 5 mL
(2 mg/mL)
For IV use ONLY
Preservative Free
STERILE ISOTONIC SOLUTION5 mL Single Dose Vial

vial
(click image for full-size original)

Package/Label Display Panel

NDC 0143-9085 -01 Rx only
DOXOrubicin
HCl Injection, USP
20 mg per 10 mL
(2 mg/mL)
For Intravenous use ONLY
Preservative Free
STERILE ISOTONIC SOLUTION10 mL Single Dose Vial

vial
(click image for full-size original)

Package/Label Display Panel

NDC 0143-9086 -01 Rx only
DOXOrubicin
HCl Injection, USP
50 mg per 25 mL
(2 mg/mL)
For Intravenous use ONLY
Preservative FreeSTERILE ISOTONIC SOLUTION

vial
(click image for full-size original)

Package/Label Display Panel

NDC 0143-9087 -01 Rx only
DOXOrubicin
HCl Injection, USP
200 mg per 100 mL
(2 mg/mL)
For Intravenous use ONLY
Preservative Free
STERILE ISOTONIC SOLUTION100 mL Multiple Dose Vial

vial
(click image for full-size original)

SERIALIZATION IMAGE 100 ML CARTON

Representative Carton Serialization Image

Representative Carton Serialization Image

SERIALIZATION IMAGE 5 ML, 10 ML, AND 25 ML CARTON

Representative Carton Serialization Image

Representative Carton Serialization Image

DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9084
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXORUBICIN HYDROCHLORIDE (DOXORUBICIN) DOXORUBICIN HYDROCHLORIDE 2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID
SODIUM CHLORIDE 9 mg in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9084-01 1 VIAL in 1 BOX contains a VIAL
1 5 mL in 1 VIAL This package is contained within the BOX (0143-9084-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062975 05/01/1996
DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9085
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXORUBICIN HYDROCHLORIDE (DOXORUBICIN) DOXORUBICIN HYDROCHLORIDE 2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID
SODIUM CHLORIDE 9 mg in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9085-01 1 VIAL in 1 BOX contains a VIAL
1 10 mL in 1 VIAL This package is contained within the BOX (0143-9085-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062975 05/01/1996
DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9086
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXORUBICIN HYDROCHLORIDE (DOXORUBICIN) DOXORUBICIN HYDROCHLORIDE 2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID
SODIUM CHLORIDE 9 mg in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9086-01 1 VIAL in 1 BOX contains a VIAL
1 25 mL in 1 VIAL This package is contained within the BOX (0143-9086-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062975 05/01/1996
DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9087
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXORUBICIN HYDROCHLORIDE (DOXORUBICIN) DOXORUBICIN HYDROCHLORIDE 2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID
SODIUM CHLORIDE 9 mg in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9087-01 1 VIAL, MULTI-DOSE in 1 BOX contains a VIAL, MULTI-DOSE
1 100 mL in 1 VIAL, MULTI-DOSE This package is contained within the BOX (0143-9087-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064097 05/01/1996
Labeler — Hikma Pharmaceuticals USA Inc. (001230762)

Revised: 03/2021 Hikma Pharmaceuticals USA Inc.

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