NDC 55513-546

NEUPOGEN

Filgrastim

NEUPOGEN is a Intravenous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Amgen Inc. The primary component is Filgrastim.

Product ID55513-546_37a4c6e3-f99d-4526-b43a-82bb8d861c33
NDC55513-546
Product TypeHuman Prescription Drug
Proprietary NameNEUPOGEN
Generic NameFilgrastim
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS; SUBCUTANEOUS
Marketing Start Date1997-04-07
Marketing CategoryBLA / BLA
Application NumberBLA103353
Labeler NameAmgen Inc
Substance NameFILGRASTIM
Active Ingredient Strength480 ug/1.6mL
Pharm ClassesGranulocyte Colony-Stimulating Factor [CS], Granulocyte-Macrophage Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 55513-546-10

10 VIAL in 1 BOX (55513-546-10) > 1.6 mL in 1 VIAL (55513-546-01)
Marketing Start Date1997-04-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55513-546-10 [55513054610]

NEUPOGEN INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103353
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1997-04-07

NDC 55513-546-01 [55513054601]

NEUPOGEN INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103353
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1997-04-07

Drug Details

Active Ingredients

IngredientStrength
FILGRASTIM480 ug/1.6mL

OpenFDA Data

SPL SET ID:97cc73cc-b5b7-458a-a933-77b00523e193
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 727545
  • 727544
  • 1649963
  • 1649964
  • 1649946
  • 1649944
  • 727535
  • 727537
  • Pharmacological Class

    • Granulocyte Colony-Stimulating Factor [CS]
    • Granulocyte-Macrophage Colony-Stimulating Factor [CS]
    • Increased Myeloid Cell Production [PE]
    • Leukocyte Growth Factor [EPC]

    NDC Crossover Matching brand name "NEUPOGEN" or generic name "Filgrastim"

    NDCBrand NameGeneric Name
    55513-209NEUPOGENFilgrastim
    55513-530NEUPOGENFilgrastim
    55513-546NEUPOGENFilgrastim
    55513-924NEUPOGENFilgrastim
    70121-1568RELEUKOFilgrastim
    70121-1569RELEUKOFilgrastim
    70121-1570RELEUKOFilgrastim
    70121-1571RELEUKOFilgrastim

    Trademark Results [NEUPOGEN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NEUPOGEN
    NEUPOGEN
    73820719 1597117 Live/Registered
    AMGEN INC.
    1989-08-05
    NEUPOGEN
    NEUPOGEN
    73749907 1607975 Live/Registered
    AMGEN INC.
    1988-09-02

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