venofer

Generic: iron sucrose

Labeler: fresenius medical care holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name venofer
Generic Name iron sucrose
Labeler fresenius medical care holdings, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

iron sucrose 20 mg/mL

Manufacturer
Fresenius Medical Care Holdings, Inc.

Identifiers & Regulatory

Product NDC 49230-534
Product ID 49230-534_e12cb876-ae80-416b-9bd3-a1cc83c9e666
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021135
Listing Expiration 2026-12-31
Marketing Start 2008-11-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49230534
Hyphenated Format 49230-534

Supplemental Identifiers

RxCUI
1741267 1741268 1741270 1741271
UPC
0349230530254 0349230534252
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 BOX (49230-534-10) / 5 mL in 1 VIAL, SINGLE-DOSE (49230-534-01)
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (49230-534-25) / 5 mL in 1 VIAL, SINGLE-DOSE (49230-534-01)
source: ndc

Packages (2)

49230-534-10 10 VIAL, SINGLE-DOSE in 1 BOX (49230-534-10) / 5 mL in 1 VIAL, SINGLE-DOSE (49230-534-01) 49230-534-25 25 VIAL, SINGLE-DOSE in 1 TRAY (49230-534-25) / 5 mL in 1 VIAL, SINGLE-DOSE (49230-534-01)

Ingredients (1)

iron sucrose (20 mg/mL)

Linked Drug Pages (1)

Venofer ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e12cb876-ae80-416b-9bd3-a1cc83c9e666", "openfda": {"nui": ["M0011718", "N0000177913"], "upc": ["0349230530254", "0349230534252"], "unii": ["FZ7NYF5N8L"], "rxcui": ["1741267", "1741268", "1741270", "1741271"], "spl_set_id": ["f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040"], "pharm_class_cs": ["Iron [CS]"], "pharm_class_epc": ["Parenteral Iron Replacement [EPC]"], "manufacturer_name": ["Fresenius Medical Care Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 BOX (49230-534-10)  / 5 mL in 1 VIAL, SINGLE-DOSE (49230-534-01)", "package_ndc": "49230-534-10", "marketing_start_date": "20081104"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (49230-534-25)  / 5 mL in 1 VIAL, SINGLE-DOSE (49230-534-01)", "package_ndc": "49230-534-25", "marketing_start_date": "20081104"}], "brand_name": "Venofer", "product_id": "49230-534_e12cb876-ae80-416b-9bd3-a1cc83c9e666", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Iron [CS]", "Parenteral Iron Replacement [EPC]", "Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "49230-534", "generic_name": "iron sucrose", "labeler_name": "Fresenius Medical Care Holdings, 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": "20081104", "listing_expiration_date": "20261231"}