iron sucrose

Generic: iron sucrose

Labeler: international medication systems, limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name iron sucrose
Generic Name iron sucrose
Labeler international medication systems, limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

iron sucrose 20 mg/mL

Manufacturer
International Medication Systems, Limited

Identifiers & Regulatory

Product NDC 76329-9201
Product ID 76329-9201_fcb13838-c298-4123-9042-237ad662d6d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208977
Listing Expiration 2026-12-31
Marketing Start 2025-08-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 763299201
Hyphenated Format 76329-9201

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 ANDA208977 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 PACKAGE (76329-9201-1) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

76329-9201-1 10 VIAL, SINGLE-DOSE in 1 PACKAGE (76329-9201-1) / 5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

iron sucrose (20 mg/mL)

Linked Drug Pages (1)

Iron Sucrose ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "fcb13838-c298-4123-9042-237ad662d6d5", "openfda": {"nui": ["M0011718", "N0000177913"], "unii": ["FZ7NYF5N8L"], "rxcui": ["1741261", "1741267", "1741270"], "spl_set_id": ["6f19c80e-22e9-4bab-aa53-4d2d958119ed"], "pharm_class_cs": ["Iron [CS]"], "pharm_class_epc": ["Parenteral Iron Replacement [EPC]"], "manufacturer_name": ["International Medication Systems, Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 PACKAGE (76329-9201-1)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "76329-9201-1", "marketing_start_date": "20250812"}], "brand_name": "Iron Sucrose", "product_id": "76329-9201_fcb13838-c298-4123-9042-237ad662d6d5", "dosage_form": "INJECTION", "pharm_class": ["Iron [CS]", "Parenteral Iron Replacement [EPC]", "Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "76329-9201", "generic_name": "Iron Sucrose", "labeler_name": "International Medication Systems, Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Iron Sucrose", "active_ingredients": [{"name": "IRON SUCROSE", "strength": "20 mg/mL"}], "application_number": "ANDA208977", "marketing_category": "ANDA", "marketing_start_date": "20250812", "listing_expiration_date": "20261231"}