NDC 51662-1441

IRON DEXTRAN

Iron Dextran

IRON DEXTRAN is a Intramuscular; Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Hf Acquisition Co Llc, Dba Healthfirst. The primary component is Iron Dextran.

Product ID51662-1441_9a4cd424-865e-fdd1-e053-2995a90a00ff
NDC51662-1441
Product TypeHuman Prescription Drug
Proprietary NameIRON DEXTRAN
Generic NameIron Dextran
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2019-12-22
Marketing CategoryNDA / NDA
Application NumberNDA017441
Labeler NameHF Acquisition Co LLC, DBA HealthFirst
Substance NameIRON DEXTRAN
Active Ingredient Strength50 mg/mL
Pharm ClassesIron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 51662-1441-1

2 mL in 1 VIAL, SINGLE-DOSE (51662-1441-1)
Marketing Start Date2019-12-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51662-1441-1 [51662144101]

IRON DEXTRAN INJECTION
Marketing CategoryNDA
Application NumberNDA017441
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-22

Drug Details

Active Ingredients

IngredientStrength
IRON DEXTRAN50 mg/mL

Pharmacological Class

  • Iron [CS]
  • Parenteral Iron Replacement [EPC]
  • Phosphate Binder [EPC]
  • Phosphate Chelating Activity [MoA]

NDC Crossover Matching brand name "IRON DEXTRAN" or generic name "Iron Dextran"

NDCBrand NameGeneric Name
51662-1441IRON DEXTRANIRON DEXTRAN
0023-6082INFeDIron Dextran
0404-9879INFEDiron dextran
52544-931INFeDIron Dextran
52584-086INFEDiron dextran
52584-931InfedIron Dextran

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.