sodium ferric gluconate complex in sucrose

Generic: sodium ferric gluconate complex in sucrose

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sodium ferric gluconate complex in sucrose
Generic Name sodium ferric gluconate complex in sucrose
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

sodium ferric gluconate complex 12.5 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9298
Product ID 0143-9298_4272216c-1e53-4180-a731-0592e772666f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078215
Listing Expiration 2026-12-31
Marketing Start 2011-03-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439298
Hyphenated Format 0143-9298

Supplemental Identifiers

RxCUI
242761
UNII
CC9149U2QX
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 sodium ferric gluconate complex in sucrose (source: ndc)
Generic Name sodium ferric gluconate complex in sucrose (source: ndc)
Application Number ANDA078215 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9298-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9298-01)
source: ndc

Packages (1)

0143-9298-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9298-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9298-01)

Ingredients (1)

sodium ferric gluconate complex (12.5 mg/mL)

Linked Drug Pages (1)

Sodium Ferric Gluconate Complex in Sucrose ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "4272216c-1e53-4180-a731-0592e772666f", "openfda": {"nui": ["M0011718", "N0000177913"], "unii": ["CC9149U2QX"], "rxcui": ["242761"], "spl_set_id": ["36377351-d208-4363-8826-0acfea3f0cc1"], "pharm_class_cs": ["Iron [CS]"], "pharm_class_epc": ["Parenteral Iron Replacement [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9298-10)  / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9298-01)", "package_ndc": "0143-9298-10", "marketing_start_date": "20110331"}], "brand_name": "Sodium Ferric Gluconate Complex in Sucrose", "product_id": "0143-9298_4272216c-1e53-4180-a731-0592e772666f", "dosage_form": "INJECTION", "pharm_class": ["Iron [CS]", "Parenteral Iron Replacement [EPC]", "Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "0143-9298", "generic_name": "Sodium Ferric Gluconate Complex in Sucrose", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sodium Ferric Gluconate Complex in Sucrose", "active_ingredients": [{"name": "SODIUM FERRIC GLUCONATE COMPLEX", "strength": "12.5 mg/mL"}], "application_number": "ANDA078215", "marketing_category": "ANDA", "marketing_start_date": "20110331", "listing_expiration_date": "20261231"}