infed

Generic: iron dextran

Labeler: henry schein, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name infed
Generic Name iron dextran
Labeler henry schein, inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

iron dextran 50 mg/mL

Manufacturer
Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9879
Product ID 0404-9879_6d143a9f-af68-48d6-a2ef-92044ac3223a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA017441
Listing Expiration 2026-12-31
Marketing Start 2022-01-11

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 04049879
Hyphenated Format 0404-9879

Supplemental Identifiers

RxCUI
206216 311144
UNII
95HR524N2M

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 infed (source: ndc)
Generic Name iron dextran (source: ndc)
Application Number NDA017441 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9879-02) / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0404-9879-02 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9879-02) / 2 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

iron dextran (50 mg/mL)

Linked Drug Pages (1)

INFED ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "6d143a9f-af68-48d6-a2ef-92044ac3223a", "openfda": {"unii": ["95HR524N2M"], "rxcui": ["206216", "311144"], "spl_set_id": ["99bf34be-cb8a-46d1-9637-5544dc2da287"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 BAG (0404-9879-02)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0404-9879-02", "marketing_start_date": "20220111"}], "brand_name": "INFED", "product_id": "0404-9879_6d143a9f-af68-48d6-a2ef-92044ac3223a", "dosage_form": "INJECTION", "pharm_class": ["Iron [CS]", "Parenteral Iron Replacement [EPC]", "Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "0404-9879", "generic_name": "iron dextran", "labeler_name": "Henry Schein, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "INFED", "active_ingredients": [{"name": "IRON DEXTRAN", "strength": "50 mg/mL"}], "application_number": "NDA017441", "marketing_category": "NDA", "marketing_start_date": "20220111", "listing_expiration_date": "20261231"}