iron sucrose

Generic: iron sucrose

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name iron sucrose
Generic Name iron sucrose
Labeler sandoz inc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

iron sucrose 50 mg/2.5mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-3485
Product ID 0781-3485_78c04f10-0489-4e45-8cb5-28a6789d1149
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212340
Listing Expiration 2026-12-31
Marketing Start 2025-09-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07813485
Hyphenated Format 0781-3485

Supplemental Identifiers

RxCUI
1741261 1741267 1741270
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 iron sucrose (source: ndc)
Generic Name iron sucrose (source: ndc)
Application Number ANDA212340 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/2.5mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3485-95) / 2.5 mL in 1 VIAL, SINGLE-DOSE (0781-3485-56)
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (0781-3485-96) / 2.5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

0781-3485-95 10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3485-95) / 2.5 mL in 1 VIAL, SINGLE-DOSE (0781-3485-56) 0781-3485-96 25 VIAL, SINGLE-DOSE in 1 CARTON (0781-3485-96) / 2.5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

iron sucrose (50 mg/2.5mL)

Linked Drug Pages (1)

Iron Sucrose ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "78c04f10-0489-4e45-8cb5-28a6789d1149", "openfda": {"nui": ["M0011718", "N0000177913"], "unii": ["FZ7NYF5N8L"], "rxcui": ["1741261", "1741267", "1741270"], "spl_set_id": ["78c04f10-0489-4e45-8cb5-28a6789d1149"], "pharm_class_cs": ["Iron [CS]"], "pharm_class_epc": ["Parenteral Iron Replacement [EPC]"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3485-95)  / 2.5 mL in 1 VIAL, SINGLE-DOSE (0781-3485-56)", "package_ndc": "0781-3485-95", "marketing_start_date": "20250922"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (0781-3485-96)  / 2.5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0781-3485-96", "marketing_start_date": "20250922"}], "brand_name": "Iron Sucrose", "product_id": "0781-3485_78c04f10-0489-4e45-8cb5-28a6789d1149", "dosage_form": "INJECTION", "pharm_class": ["Iron [CS]", "Parenteral Iron Replacement [EPC]", "Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "0781-3485", "generic_name": "Iron Sucrose", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Iron Sucrose", "active_ingredients": [{"name": "IRON SUCROSE", "strength": "50 mg/2.5mL"}], "application_number": "ANDA212340", "marketing_category": "ANDA", "marketing_start_date": "20250922", "listing_expiration_date": "20261231"}