DESFERAL- deferoxamine mesylate injection, powder, for solution
MITEM PHARMA

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Desferal LBL Desferal PI USA

DESFERAL
deferoxamine mesylate injection, powder, for solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:87081-467
Route of Administration	SUBCUTANEOUS, INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEFEROXAMINE MESYLATE (UNII: V9TKO7EO6K) (DEFEROXAMINE - UNII:J06Y7MXW4D)	DEFEROXAMINE MESYLATE	500 mg in 5 mL

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:87081-467-91	4 mL in 1 VIAL; Type 0: Not a Combination Product	04/02/1968

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA016267	04/02/1968

Labeler - MITEM PHARMA (500300624)

Name	Address	ID/FEI	Business Operations
Establishment
Excella GmbH & Co. KG Nürnberger Str. 12 90537 Feucht Germany		329809800	api manufacture(87081-467) , analysis(87081-467)

Name	Address	ID/FEI	Business Operations
Establishment
Novartis Pharma AG Lichtstrasse 35 CH-4056 Basel Switzerland		482347168	analysis(87081-467)

Name	Address	ID/FEI	Business Operations
Establishment
SGS International Services Laboratory (ISL) Limited Ringaskiddy Cork, P43 FR 63 Ireland (IRL)		985785798	analysis(87081-467)

Name	Address	ID/FEI	Business Operations
Establishment
SGS Institut Fresenius GmbH Tegeler Weg 33 10589 Berlin Germany		341259550	analysis(87081-467)

Name	Address	ID/FEI	Business Operations
Establishment
SGS Institut Fresenius GmbH Im Maisel 14 65232 Taunusstein Germany		317219699	analysis(87081-467)

Name	Address	ID/FEI	Business Operations
Establishment
Novartis Pharma Stein AG Schaffhauserstrasse 4332 Stein Switzerland		488152505	manufacture(87081-467) , analysis(87081-467) , pack(87081-467)

Name	Address	ID/FEI	Business Operations
Establishment
Pharmanalytica SA Via Balestra 6600 Locarno Switzerland		487967499	analysis(87081-467)

Name	Address	ID/FEI	Business Operations
Establishment
Packaging Coordinators, LLC 3001 Red Lion Road Philadelphia, PA 19114		078525133	pack(87081-467)

Name	Address	ID/FEI	Business Operations
Establishment
Wasserburger Arzneimittelwerk GmbH Herderstraβe 1,2 and Molkerei-Bauer-Straβe 18 83512 Wasserburg Germany		326482247	manufacture(87081-467) , analysis(87081-467) , pack(87081-467)

Name	Address	ID/FEI	Business Operations
Establishment
Labor LS SE & Co. KG Mangelsfeld 4, 5, 6, Bad Bocklet, Bavaria 97708 Germany		314929072	analysis(87081-467)

Name	Address	ID/FEI	Business Operations
Establishment
Solvias AG Römerpark 2 4303 Kaiseraugst Switzerland		480739627	analysis(87081-467)

Revised: 7/2025

Document Id: 38eff751-96c6-c48a-e063-6294a90a0e48

Set id: 38eff751-96c5-c48a-e063-6294a90a0e48

Version: 1

Effective Time: 20250702

MITEM PHARMA