venofer

Generic: iron sucrose

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

Drug Facts

Product Profile

Brand Name venofer
Generic Name iron sucrose
Labeler american regent, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

iron sucrose 20 mg/mL

Manufacturer
American Regent, Inc.

Identifiers & Regulatory

Product NDC 0517-2340
Product ID 0517-2340_91f50fe2-b85d-460d-86a8-469cc16f6a99
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021135
Listing Expiration 2026-12-31
Marketing Start 2014-07-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05172340
Hyphenated Format 0517-2340

Supplemental Identifiers

RxCUI
1741267 1741268
UNII
FZ7NYF5N8L
NUI
M0011718 N0000177913

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 venofer (source: ndc)
Generic Name iron sucrose (source: ndc)
Application Number NDA021135 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (0517-2340-99) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0517-2340-99 10 VIAL, SINGLE-DOSE in 1 CARTON (0517-2340-99) / 5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

iron sucrose (20 mg/mL)

Linked Drug Pages (2)

Venofer ndc-match (0.9) Venofer ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "91f50fe2-b85d-460d-86a8-469cc16f6a99", "openfda": {"nui": ["M0011718", "N0000177913"], "unii": ["FZ7NYF5N8L"], "rxcui": ["1741267", "1741268"], "spl_set_id": ["b998ef36-81fa-40a1-9cd1-6d6156f91564"], "pharm_class_cs": ["Iron [CS]"], "pharm_class_epc": ["Parenteral Iron Replacement [EPC]"], "manufacturer_name": ["American Regent, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (0517-2340-99)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0517-2340-99", "marketing_start_date": "20140714"}], "brand_name": "Venofer", "product_id": "0517-2340_91f50fe2-b85d-460d-86a8-469cc16f6a99", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Iron [CS]", "Parenteral Iron Replacement [EPC]", "Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "0517-2340", "generic_name": "iron sucrose", "labeler_name": "American Regent, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Venofer", "active_ingredients": [{"name": "IRON SUCROSE", "strength": "20 mg/mL"}], "application_number": "NDA021135", "marketing_category": "NDA", "marketing_start_date": "20140714", "listing_expiration_date": "20261231"}