NDC Code(s) : 0069-0170-01, 0069-0171-01
Packager : Pfizer Laboratories Div Pfizer Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Doxorubicin HydrochlorideDoxorubicin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-0170
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXORUBICIN HYDROCHLORIDE(UNII: 82F2G7BL4E)
(DOXORUBICIN - UNII:80168379AG) 		DOXORUBICIN HYDROCHLORIDE2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-0170-015 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200170 10/29/2011

INGREDIENTS AND APPEARANCE

Doxorubicin HydrochlorideDoxorubicin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-0171
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXORUBICIN HYDROCHLORIDE(UNII: 82F2G7BL4E)
(DOXORUBICIN - UNII:80168379AG) 		DOXORUBICIN HYDROCHLORIDE2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-0171-0125 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200170 10/29/2011

PRINCIPAL DISPLAY PANEL

Single Dose Vial

DOXOrubicin Hydrochloride for Injection, USP 50mg/Vial

Caution: Cytotoxic Agent

Lyophilized

For IV use only

Carton label

Single Dose Vial

DOXOrubicin Hydrochloride for Injection, USP 10mg/Vial

Caution: Cytotoxic Agent

Lyophilized

For IV use only

Carton label