NDC 59338-775

Feraheme

Ferumoxytol

Feraheme is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Amag Pharmaceuticals, Inc.. The primary component is Ferumoxytol Non-stoichiometric Magnetite.

• Product ID: 59338-775_76e0012f-ddf8-497a-a894-fef384d4175e
• NDC: 59338-775
• Product Type: Human Prescription Drug
• Proprietary Name: Feraheme
• Generic Name: Ferumoxytol
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2009-07-13
• Marketing Category: NDA / NDA
• Application Number: NDA022180
• Labeler Name: AMAG Pharmaceuticals, Inc.
• Substance Name: FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE
• Active Ingredient Strength: 510 mg/17mL
• Pharm Classes: Parenteral Iron Replacement [EPC],Iron [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 59338-775-01

1 VIAL, SINGLE-USE in 1 CARTON (59338-775-01) > 17 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2009-07-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59338-775-10 [59338077510]

Feraheme INJECTION

• Marketing Category: NDA
• Application Number: NDA022180
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2009-07-13

NDC 59338-775-01 [59338077501]

Feraheme INJECTION

• Marketing Category: NDA
• Application Number: NDA022180
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2009-07-13

Drug Details

Active Ingredients

Ingredient	Strength
FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE	510 mg/17mL

OpenFDA Data

• SPL SET ID: 32b0e320-a739-11dc-a704-0002a5d5c51b
• Manufacturer:
  • AMAG Pharmaceuticals, Inc.
• UNII:
  • CLH5FT6412
• RxNorm Concept Unique ID - RxCUI:
  • 1191357
  • 860605

Pharmacological Class

• Parenteral Iron Replacement [EPC]
• Iron [CS]
• Parenteral Iron Replacement [EPC]
• Iron [CS]

NDC Crossover Matching brand name "Feraheme" or generic name "Ferumoxytol"

NDC	Brand Name	Generic Name
59338-775	Feraheme	ferumoxytol
0781-3154	Ferumoxytol	ferumoxytol