Label: DESFERAL- deferoxamine mesylate injection, powder, for solution
- NDC Code(s): 87081-467-91
- Packager: MITEM PHARMA
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated July 2, 2025
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- DOSAGE FORMS & STRENGTHS
- CONTRAINDICATIONS
- WARNINGS AND PRECAUTIONS
- ADVERSE REACTIONS
- DRUG INTERACTIONS
- USE IN SPECIFIC POPULATIONS
- OVERDOSAGE
- DESCRIPTION
- CLINICAL PHARMACOLOGY
- NONCLINICAL TOXICOLOGY
- HOW SUPPLIED
- 88436-1 - Section Title Not Found In Database
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DESFERAL
deferoxamine mesylate injection, powder, for solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:87081-467 Route of Administration SUBCUTANEOUS, INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:87081-467-91 4 mL in 1 VIAL; Type 0: Not a Combination Product 04/02/1968 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA016267 04/02/1968 Labeler - MITEM PHARMA (500300624) Establishment Name Address ID/FEI Business Operations Excella GmbH & Co. KG Nürnberger Str. 12 90537 Feucht Germany 329809800 api manufacture(87081-467) , analysis(87081-467) Establishment Name Address ID/FEI Business Operations Novartis Pharma AG Lichtstrasse 35 CH-4056 Basel Switzerland 482347168 analysis(87081-467) Establishment Name Address ID/FEI Business Operations SGS International Services Laboratory (ISL) Limited Ringaskiddy Cork, P43 FR 63 Ireland (IRL) 985785798 analysis(87081-467) Establishment Name Address ID/FEI Business Operations SGS Institut Fresenius GmbH Tegeler Weg 33 10589 Berlin Germany 341259550 analysis(87081-467) Establishment Name Address ID/FEI Business Operations SGS Institut Fresenius GmbH Im Maisel 14 65232 Taunusstein Germany 317219699 analysis(87081-467) Establishment Name Address ID/FEI Business Operations Novartis Pharma Stein AG Schaffhauserstrasse 4332 Stein Switzerland 488152505 manufacture(87081-467) , analysis(87081-467) , pack(87081-467) Establishment Name Address ID/FEI Business Operations Pharmanalytica SA Via Balestra 6600 Locarno Switzerland 487967499 analysis(87081-467) Establishment Name Address ID/FEI Business Operations Packaging Coordinators, LLC 3001 Red Lion Road Philadelphia, PA 19114 078525133 pack(87081-467) Establishment Name Address ID/FEI Business Operations Wasserburger Arzneimittelwerk GmbH Herderstraβe 1,2 and Molkerei-Bauer-Straβe 18 83512 Wasserburg Germany 326482247 manufacture(87081-467) , analysis(87081-467) , pack(87081-467) Establishment Name Address ID/FEI Business Operations Labor LS SE & Co. KG Mangelsfeld 4, 5, 6, Bad Bocklet, Bavaria 97708 Germany 314929072 analysis(87081-467) Establishment Name Address ID/FEI Business Operations Solvias AG Römerpark 2 4303 Kaiseraugst Switzerland 480739627 analysis(87081-467)
