NDC 55513-283

EPOGEN

Epoetin Alfa

EPOGEN is a Intravenous; Subcutaneous Solution in the Human Prescription Drug category. It is labeled and distributed by Amgen Inc. The primary component is Erythropoietin.

Product ID55513-283_0b8ee1a8-d7d1-46c9-b688-6fbd8dcaccca
NDC55513-283
Product TypeHuman Prescription Drug
Proprietary NameEPOGEN
Generic NameEpoetin Alfa
Dosage FormSolution
Route of AdministrationINTRAVENOUS; SUBCUTANEOUS
Marketing Start Date1994-12-05
Marketing CategoryBLA / BLA
Application NumberBLA103234
Labeler NameAmgen Inc
Substance NameERYTHROPOIETIN
Active Ingredient Strength10000 [iU]/mL
Pharm ClassesErythropoiesis-stimulating Agent [EPC],Erythropoietin [CS],Increased Erythroid Cell Production [PE]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55513-283-10

10 VIAL in 1 PACKAGE (55513-283-10) > 2 mL in 1 VIAL (55513-283-01)
Marketing Start Date1994-12-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55513-283-01 [55513028301]

EPOGEN SOLUTION
Marketing CategoryBLA
Application NumberBLA103234
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1994-12-05

NDC 55513-283-10 [55513028310]

EPOGEN SOLUTION
Marketing CategoryBLA
Application NumberBLA103234
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1994-12-05

Drug Details

Active Ingredients

IngredientStrength
ERYTHROPOIETIN10000 [iU]/mL

OpenFDA Data

SPL SET ID:1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 240000
  • 1721685
  • 239998
  • 239999
  • 205912
  • 205917
  • 212218
  • 205921
  • 205923
  • 241999
  • 1721684
  • 240377
  • Pharmacological Class

    • Erythropoiesis-stimulating Agent [EPC]
    • Erythropoietin [CS]
    • Increased Erythroid Cell Production [PE]

    NDC Crossover Matching brand name "EPOGEN" or generic name "Epoetin Alfa"

    NDCBrand NameGeneric Name
    55513-126EPOGENepoetin alfa
    55513-144EPOGENepoetin alfa
    55513-148EPOGENepoetin alfa
    55513-267EPOGENepoetin alfa
    55513-283EPOGENepoetin alfa
    55513-478EPOGENepoetin alfa

    Trademark Results [EPOGEN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    EPOGEN
    EPOGEN
    73699422 1543197 Live/Registered
    AMGEN INC.
    1987-12-07

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