Doxorubicin Hydrochloride: Package Insert and Label Information (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 45963-733-68

Doxorubicin Hydrochloride Injection USP

50 mg/25 mL

(2 mg/mL)

For Intravenous Use Only

Sterile Isotonic Solution

Nonpyrogenic, Preservative-free.

Warning: Severe cellulitis vesication and tissue necrosis will occur if doxorubicin is extravasated during administration.

CAUTION: Cytotoxic Agent

Rx only

25 mL Single-Dose Vial

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 45963-733-60

Doxorubicin Hydrochloride Injection USP

200mg/100 mL

(2 mg/mL)

For Intravenous Use Only

Sterile Isotonic Solution

Nonpyrogenic, Preservative-free.

Warning: Severe cellulitis vesication and tissue necrosis will occur if doxorubicin is extravasated during administration.

CAUTION: Cytotoxic Agent

Rx only

100 mL Multi-Dose Vial

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DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45963-733
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
SODIUM CHLORIDE
WATER
HYDROCHLORIC ACID
Product Characteristics
Color red (clear) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45963-733-55 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (45963-733-55)
2 NDC:45963-733-57 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
2 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (45963-733-57)
3 NDC:45963-733-68 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
3 25 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (45963-733-68)
4 NDC:45963-733-60 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
4 100 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (45963-733-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203622 11/01/2014
Labeler — Actavis Pharma, Inc. (119723554)

Revised: 01/2021 Actavis Pharma, Inc.

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