NDC 0517-2310

Venofer

Iron Sucrose

Venofer is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by American Regent, Inc.. The primary component is Iron Sucrose.

Product ID0517-2310_0397137f-282f-44f7-95ad-34bb90938fef
NDC0517-2310
Product TypeHuman Prescription Drug
Proprietary NameVenofer
Generic NameIron Sucrose
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2007-06-12
Marketing CategoryNDA / NDA
Application NumberNDA021135
Labeler NameAmerican Regent, Inc.
Substance NameIRON SUCROSE
Active Ingredient Strength20 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 0517-2310-05

5 VIAL, SINGLE-DOSE in 1 BOX (0517-2310-05) > 10 mL in 1 VIAL, SINGLE-DOSE (0517-2310-01)
Marketing Start Date2007-06-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0517-2310-10 [00517231010]

Venofer INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021135
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-06-12
Marketing End Date2011-02-25

NDC 0517-2310-05 [00517231005]

Venofer INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021135
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2007-06-12

NDC 0517-2310-01 [00517231001]

Venofer INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021135
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-06-12

Drug Details

Active Ingredients

IngredientStrength
IRON SUCROSE20 mg/mL

OpenFDA Data

SPL SET ID:626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1741261
  • 1741271
  • 1741263
  • 1741267
  • 1741268
  • 1741270
  • UPC Code
  • 0349230534108
  • 0305172340016
  • 0305172340252
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Venofer" or generic name "Iron Sucrose"

    NDCBrand NameGeneric Name
    0517-2310Venoferiron sucrose
    0517-2325Venoferiron sucrose
    0517-2340Venoferiron sucrose
    49230-530Venoferiron sucrose
    49230-534Venoferiron sucrose
    50090-4541Venoferiron sucrose
    58607-111Myferon 150IRON SUCROSE

    Trademark Results [Venofer]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    VENOFER
    VENOFER
    75010550 not registered Dead/Abandoned
    Vifor (International) Inc.
    1995-10-26
    VENOFER
    VENOFER
    74732322 2033543 Live/Registered
    Vifor (International) Inc.
    1995-09-21

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