venofer (iron sucrose) (51662-1568)

Drug Facts

Product Profile

Brand Name venofer (iron sucrose)

Generic Name venofer (iron sucrose)

Labeler hf acquisition co llc, dba healthfirst

Dosage Form INJECTION, SOLUTION

Routes

INTRAVENOUS

Active Ingredients

iron sucrose 20 mg/mL

Manufacturer

HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1568

Product ID 51662-1568_1677c959-a5e5-8d41-e063-6294a90a4ebe

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category NDA

Application Number NDA021135

Listing Expiration 2026-12-31

Marketing Start 2021-06-25

Pharmacologic Class

Established (EPC)

parenteral iron replacement [epc]

Chemical Structure

iron [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516621568

Hyphenated Format 51662-1568

Supplemental Identifiers

RxCUI

1741267

UNII

FZ7NYF5N8L

NUI

M0011718 N0000177913

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 venofer (iron sucrose) (source: ndc)

Generic Name venofer (iron sucrose) (source: ndc)

Application Number NDA021135 (source: ndc)

Routes

INTRAVENOUS

source: ndc

Resolved Composition

Strengths

20 mg/mL

source: ndc

Packaging

10 POUCH in 1 CASE (51662-1568-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1568-2) / 5 mL in 1 VIAL, SINGLE-DOSE (51662-1568-1)

source: ndc

Packages (1)

51662-1568-3 10 POUCH in 1 CASE (51662-1568-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1568-2) / 5 mL in 1 VIAL, SINGLE-DOSE (51662-1568-1)

Ingredients (1)

iron sucrose (20 mg/mL)

Linked Drug Pages (1)

VENOFER (IRON SUCROSE) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRAVENOUS"], "spl_id": "1677c959-a5e5-8d41-e063-6294a90a4ebe", "openfda": {"nui": ["M0011718", "N0000177913"], "unii": ["FZ7NYF5N8L"], "rxcui": ["1741267"], "spl_set_id": ["c59cb54c-bee5-96d6-e053-2995a90a767c"], "pharm_class_cs": ["Iron [CS]"], "pharm_class_epc": ["Parenteral Iron Replacement [EPC]"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "10 POUCH in 1 CASE (51662-1568-3)  / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1568-2)  / 5 mL in 1 VIAL, SINGLE-DOSE (51662-1568-1)", "package_ndc": "51662-1568-3", "marketing_start_date": "20210625"}], "brand_name": "VENOFER (IRON SUCROSE)", "product_id": "51662-1568_1677c959-a5e5-8d41-e063-6294a90a4ebe", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Iron [CS]", "Parenteral Iron Replacement [EPC]", "Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "51662-1568", "generic_name": "VENOFER (IRON SUCROSE)", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VENOFER (IRON SUCROSE)", "active_ingredients": [{"name": "IRON SUCROSE", "strength": "20 mg/mL"}], "application_number": "NDA021135", "marketing_category": "NDA", "marketing_start_date": "20210625", "listing_expiration_date": "20261231"}