Deferoxamine Mesylate (Page 3 of 3)

HOW SUPPLIED

Unit of SaleConcentration
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 Hospira Logo

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 Label
(click image for full-size original)

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 -- 500 mg Vial Carton
(click image for full-size original)

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 Label
(click image for full-size original)

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

PRINCIPAL DISPLAY PANEL -- 2 g Vial Carton
(click image for full-size original)
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.

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