NDC 0143-9298

Sodium Ferric Gluconate Complex in Sucrose

Sodium Ferric Gluconate Complex In Sucrose

Sodium Ferric Gluconate Complex in Sucrose is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Sodium Ferric Gluconate Complex.

Product ID0143-9298_0773cd05-6e92-4bff-aef7-eda5d81f6796
NDC0143-9298
Product TypeHuman Prescription Drug
Proprietary NameSodium Ferric Gluconate Complex in Sucrose
Generic NameSodium Ferric Gluconate Complex In Sucrose
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2011-03-31
Marketing CategoryANDA / ANDA
Application NumberANDA078215
Labeler NameHikma Pharmaceuticals USA Inc.
Substance NameSODIUM FERRIC GLUCONATE COMPLEX
Active Ingredient Strength13 mg/mL
Pharm ClassesIron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0143-9298-10

10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9298-10) > 5 mL in 1 VIAL, SINGLE-DOSE (0143-9298-01)
Marketing Start Date2011-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0143-9298-10 [00143929810]

Sodium Ferric Gluconate Complex in Sucrose INJECTION
Marketing CategoryANDA
Application NumberANDA078215
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-03-31

NDC 0143-9298-01 [00143929801]

Sodium Ferric Gluconate Complex in Sucrose INJECTION
Marketing CategoryANDA
Application NumberANDA078215
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-03-31

Drug Details

Active Ingredients

IngredientStrength
SODIUM FERRIC GLUCONATE COMPLEX12.5 mg/mL

OpenFDA Data

SPL SET ID:36377351-d208-4363-8826-0acfea3f0cc1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 242761
  • Pharmacological Class

    • Iron [CS]
    • Parenteral Iron Replacement [EPC]
    • Phosphate Binder [EPC]
    • Phosphate Chelating Activity [MoA]
    • Iron [CS]
    • Parenteral Iron Replacement [EPC]
    • Phosphate Binder [EPC]
    • Phosphate Chelating Activity [MoA]

    NDC Crossover Matching brand name "Sodium Ferric Gluconate Complex in Sucrose" or generic name "Sodium Ferric Gluconate Complex In Sucrose"

    NDCBrand NameGeneric Name
    0143-9298Sodium Ferric Gluconate Complex in SucroseSodium Ferric Gluconate Complex in Sucrose
    0143-9570Sodium Ferric Gluconate Complex in SucroseSodium Ferric Gluconate Complex in Sucrose
    0591-2508Sodium Ferric Gluconate Complex in SucroseSodium Ferric Gluconate Complex

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