iron sucrose

Generic: iron sucrose

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name iron sucrose
Generic Name iron sucrose
Labeler mylan institutional llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

iron sucrose 200 mg/10mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-639
Product ID 67457-639_3f109bdb-a412-43b2-84c7-9dad05e85a71
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212559
Listing Expiration 2026-12-31
Marketing Start 2025-08-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457639
Hyphenated Format 67457-639

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 ANDA212559 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/10mL
source: ndc
Packaging
  • 5 VIAL, SINGLE-DOSE in 1 CARTON (67457-639-10) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

67457-639-10 5 VIAL, SINGLE-DOSE in 1 CARTON (67457-639-10) / 10 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

iron sucrose (200 mg/10mL)

Linked Drug Pages (1)

Iron Sucrose ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3f109bdb-a412-43b2-84c7-9dad05e85a71", "openfda": {"nui": ["M0011718", "N0000177913"], "unii": ["FZ7NYF5N8L"], "rxcui": ["1741261", "1741267", "1741270"], "spl_set_id": ["3f109bdb-a412-43b2-84c7-9dad05e85a71"], "pharm_class_cs": ["Iron [CS]"], "pharm_class_epc": ["Parenteral Iron Replacement [EPC]"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, SINGLE-DOSE in 1 CARTON (67457-639-10)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "67457-639-10", "marketing_start_date": "20250811"}], "brand_name": "Iron Sucrose", "product_id": "67457-639_3f109bdb-a412-43b2-84c7-9dad05e85a71", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Iron [CS]", "Parenteral Iron Replacement [EPC]", "Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "67457-639", "generic_name": "Iron Sucrose", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Iron Sucrose", "active_ingredients": [{"name": "IRON SUCROSE", "strength": "200 mg/10mL"}], "application_number": "ANDA212559", "marketing_category": "ANDA", "marketing_start_date": "20250811", "listing_expiration_date": "20261231"}