NDC 0024-2792

Ferrlecit

Sodium Ferric Gluconate Complex

Ferrlecit is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Sanofi-aventis U.s. Llc. The primary component is Sodium Ferric Gluconate Complex.

Product ID0024-2792_17761b93-038d-494e-b6bb-7e1698db3d64
NDC0024-2792
Product TypeHuman Prescription Drug
Proprietary NameFerrlecit
Generic NameSodium Ferric Gluconate Complex
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2011-03-01
Marketing CategoryNDA / NDA
Application NumberNDA020955
Labeler Namesanofi-aventis U.S. LLC
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 0024-2792-10

10 VIAL, SINGLE-USE in 1 CARTON (0024-2792-10) > 5 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2011-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0024-2792-10 [00024279210]

Ferrlecit INJECTION
Marketing CategoryNDA
Application NumberNDA020955
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-03-01

Drug Details

Active Ingredients

IngredientStrength
SODIUM FERRIC GLUCONATE COMPLEX12.5 mg/mL

OpenFDA Data

SPL SET ID:1fe028ff-42ac-4329-b1a5-a9dadfcb79f6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 261123
  • 242761
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Ferrlecit" or generic name "Sodium Ferric Gluconate Complex"

    NDCBrand NameGeneric Name
    0024-2792Ferrlecitsodium ferric gluconate complex
    0024-2794Ferrlecitsodium ferric gluconate complex
    0591-0149Sodium Ferric Gluconate ComplexSodium Ferric Gluconate Complex
    0591-2508Sodium Ferric Gluconate Complex in SucroseSodium Ferric Gluconate Complex

    Trademark Results [Ferrlecit]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FERRLECIT
    FERRLECIT
    75047697 2408958 Live/Registered
    A. NATTERMANN & CIE. GmbH
    1996-01-24

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