NDC 0143-9570

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 ID0143-9570_10fa131a-5548-478f-bf76-11101d321387
NDC0143-9570
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 Through2021-12-31

Packaging

NDC 0143-9570-10

10 VIAL in 1 CARTON (0143-9570-10) > 5 mL in 1 VIAL (0143-9570-01)
Marketing Start Date2011-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0143-9570-01 [00143957001]

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

NDC 0143-9570-10 [00143957010]

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:218d1b8d-b24f-4f77-b588-97c7dd1c2eec
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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.