injectafer

Generic: ferric carboxymaltose

Labeler: american regent, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name injectafer
Generic Name ferric carboxymaltose
Labeler american regent, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

ferric carboxymaltose 50 mg/mL

Manufacturer
American Regent, Inc.

Identifiers & Regulatory

Product NDC 0517-0620
Product ID 0517-0620_a092ebb6-505b-464f-9669-194a913ff8e5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203565
Listing Expiration 2026-12-31
Marketing Start 2021-06-01

Pharmacologic Class

Classes
iron [cs] parenteral iron replacement [epc] phosphate binder [epc] phosphate chelating activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05170620
Hyphenated Format 0517-0620

Supplemental Identifiers

RxCUI
1435169 1435174 2552400 2552401 2602296 2602297
UNII
6897GXD6OE

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 injectafer (source: ndc)
Generic Name ferric carboxymaltose (source: ndc)
Application Number NDA203565 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 BOX (0517-0620-01) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0517-0620-01 1 VIAL, SINGLE-DOSE in 1 BOX (0517-0620-01) / 20 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

ferric carboxymaltose (50 mg/mL)

Linked Drug Pages (1)

Injectafer ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "a092ebb6-505b-464f-9669-194a913ff8e5", "openfda": {"unii": ["6897GXD6OE"], "rxcui": ["1435169", "1435174", "2552400", "2552401", "2602296", "2602297"], "spl_set_id": ["517b4a19-45b3-4286-9f6a-ced4e10447de"], "manufacturer_name": ["American Regent, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 BOX (0517-0620-01)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0517-0620-01", "marketing_start_date": "20210601"}], "brand_name": "Injectafer", "product_id": "0517-0620_a092ebb6-505b-464f-9669-194a913ff8e5", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Iron [CS]", "Parenteral Iron Replacement [EPC]", "Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "0517-0620", "generic_name": "Ferric Carboxymaltose", "labeler_name": "American Regent, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Injectafer", "active_ingredients": [{"name": "FERRIC CARBOXYMALTOSE", "strength": "50 mg/mL"}], "application_number": "NDA203565", "marketing_category": "NDA", "marketing_start_date": "20210601", "listing_expiration_date": "20261231"}