feraheme

Generic: ferumoxytol

Labeler: amag pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name feraheme
Generic Name ferumoxytol
Labeler amag pharmaceuticals, inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

ferumoxytol non-stoichiometric magnetite 510 mg/17mL

Manufacturer
AMAG Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 59338-775
Product ID 59338-775_69a91fd4-deed-452e-b700-ea68b6e85421
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022180
Listing Expiration 2026-12-31
Marketing Start 2009-07-13

Pharmacologic Class

Established (EPC)
parenteral iron replacement [epc]
Chemical Structure
iron [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59338775
Hyphenated Format 59338-775

Supplemental Identifiers

RxCUI
860605 1191357
UNII
CLH5FT6412
NUI
N0000177913 M0011718

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name feraheme (source: ndc)
Generic Name ferumoxytol (source: ndc)
Application Number NDA022180 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 510 mg/17mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (59338-775-01) / 17 mL in 1 VIAL, SINGLE-USE
  • 10 VIAL, SINGLE-USE in 1 CARTON (59338-775-10) / 17 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (2)

59338-775-01 1 VIAL, SINGLE-USE in 1 CARTON (59338-775-01) / 17 mL in 1 VIAL, SINGLE-USE 59338-775-10 10 VIAL, SINGLE-USE in 1 CARTON (59338-775-10) / 17 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

ferumoxytol non-stoichiometric magnetite (510 mg/17mL)

Linked Drug Pages (1)

Feraheme ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "69a91fd4-deed-452e-b700-ea68b6e85421", "openfda": {"nui": ["N0000177913", "M0011718"], "unii": ["CLH5FT6412"], "rxcui": ["860605", "1191357"], "spl_set_id": ["32b0e320-a739-11dc-a704-0002a5d5c51b"], "pharm_class_cs": ["Iron [CS]"], "pharm_class_epc": ["Parenteral Iron Replacement [EPC]"], "manufacturer_name": ["AMAG Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (59338-775-01)  / 17 mL in 1 VIAL, SINGLE-USE", "package_ndc": "59338-775-01", "marketing_start_date": "20090713"}, {"sample": false, "description": "10 VIAL, SINGLE-USE in 1 CARTON (59338-775-10)  / 17 mL in 1 VIAL, SINGLE-USE", "package_ndc": "59338-775-10", "marketing_start_date": "20090713"}], "brand_name": "Feraheme", "product_id": "59338-775_69a91fd4-deed-452e-b700-ea68b6e85421", "dosage_form": "INJECTION", "pharm_class": ["Iron [CS]", "Parenteral Iron Replacement [EPC]"], "product_ndc": "59338-775", "generic_name": "ferumoxytol", "labeler_name": "AMAG Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Feraheme", "active_ingredients": [{"name": "FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE", "strength": "510 mg/17mL"}], "application_number": "NDA022180", "marketing_category": "NDA", "marketing_start_date": "20090713", "listing_expiration_date": "20261231"}