Prescription Drug Information: Deferoxamine Mesylate (Page 3 of 3)

HOW SUPPLIED

Unit of Sale	Concentration
NDC 0409-2336-10	500 mg
Carton of 4 Single-dose
Fliptop vials
NDC 0409-2337-25	2 g
Carton of 4 Single-dose
Fliptop vials

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

For single-dose only.

Discard unused portion.

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

LAB-1006-3.0

Revised: 8/2020

PRINCIPAL DISPLAY PANEL — 500 mg Vial Label

Single-dose Vial
Rx only

Deferoxamine
Mesylate
for Injection, USP

500 mg/vial

INTRAVENOUS,
INTRAMUSCULAR, SUBCUTANEOUS USE

Distributed byHospira, Inc., Lake Forest, IL 60045 USA

PRINCIPAL DISPLAY PANEL — 500 mg Vial Carton

4 Single-dose Vials
Rx only
NDC 0409-2336-10
Contains 4 of NDC 0409-2336-01

Deferoxamine Mesylate
for Injection, USP

500 mg/vial

Hospira

Each vial contains deferoxamine mesylate USP, 500 mg in
lyophilized form.
INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS USEDiscard unused portion.

PRINCIPAL DISPLAY PANEL — 2 g Vial Label

Fliptop Vial
Rx only

Deferoxamine
Mesylate for Injection, USP

2 g/vial

For single-dose only.

For S.C., I.M. or I.V. Use

PRINCIPAL DISPLAY PANEL — 2 g Vial Carton

4 Fliptop Vials
Rx only
NDC 0409-2337-25
Contains 4 of NDC 0409-2337-15

Deferoxamine Mesylate
for Injection, USP

2 g/vial

Hospira

Each vial contains deferoxamine mesylate USP, 2 g in lyophilized form.
For subcutaneous, intramuscular or intravenous administration.For single-dose only. Discard unused portion.

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

DEFEROXAMINE MESYLATE deferoxamine mesylate injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-2336 Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEFEROXAMINE MESYLATE (DEFEROXAMINE) DEFEROXAMINE MESYLATE 500 mg

Inactive Ingredients Ingredient Name Strength WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0409-2336-10 4 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE (0409-2336-01) 1 NDC:0409-2336-01 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE This package is contained within the CARTON (0409-2336-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076019 04/30/2005 09/01/2021

DEFEROXAMINE MESYLATE deferoxamine mesylate injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-2337 Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEFEROXAMINE MESYLATE (DEFEROXAMINE) DEFEROXAMINE MESYLATE 2 g

Inactive Ingredients Ingredient Name Strength WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0409-2337-25 4 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE (0409-2337-15) 1 NDC:0409-2337-15 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE This package is contained within the CARTON (0409-2337-25)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076019 03/31/2005

Labeler — Hospira, Inc. (141588017)

Establishment
Name	Address	ID/FEI	Operations
Hospira, Inc.		030606222	ANALYSIS (0409-2336), ANALYSIS (0409-2337), MANUFACTURE (0409-2336), MANUFACTURE (0409-2337), PACK (0409-2336), PACK (0409-2337), LABEL (0409-2336), LABEL (0409-2337)

Revised: 04/2021 Hospira, Inc.