ferumoxytol

Generic: ferumoxytol

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ferumoxytol
Generic Name ferumoxytol
Labeler sandoz inc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

ferumoxytol non-stoichiometric magnetite 510 mg/17mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-3154
Product ID 0781-3154_7374e3ff-0761-45f0-bb76-bf1b74a20480
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206604
Listing Expiration 2027-12-31
Marketing Start 2021-07-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07813154
Hyphenated Format 0781-3154

Supplemental Identifiers

RxCUI
860605
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 ferumoxytol (source: ndc)
Generic Name ferumoxytol (source: ndc)
Application Number ANDA206604 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 510 mg/17mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3154-01) / 17 mL in 1 VIAL, SINGLE-DOSE
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3154-95) / 17 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

0781-3154-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3154-01) / 17 mL in 1 VIAL, SINGLE-DOSE 0781-3154-95 10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3154-95) / 17 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

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

Linked Drug Pages (1)

Ferumoxytol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "7374e3ff-0761-45f0-bb76-bf1b74a20480", "openfda": {"nui": ["N0000177913", "M0011718"], "unii": ["CLH5FT6412"], "rxcui": ["860605"], "spl_set_id": ["cf94c7fc-13a0-4ac9-bb85-9c38aa704d35"], "pharm_class_cs": ["Iron [CS]"], "pharm_class_epc": ["Parenteral Iron Replacement [EPC]"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3154-01)  / 17 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0781-3154-01", "marketing_start_date": "20210715"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3154-95)  / 17 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0781-3154-95", "marketing_start_date": "20210715"}], "brand_name": "Ferumoxytol", "product_id": "0781-3154_7374e3ff-0761-45f0-bb76-bf1b74a20480", "dosage_form": "INJECTION", "pharm_class": ["Iron [CS]", "Parenteral Iron Replacement [EPC]"], "product_ndc": "0781-3154", "generic_name": "ferumoxytol", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ferumoxytol", "active_ingredients": [{"name": "FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE", "strength": "510 mg/17mL"}], "application_number": "ANDA206604", "marketing_category": "ANDA", "marketing_start_date": "20210715", "listing_expiration_date": "20271231"}