NDC 0069-0294

Nivestym

Filgrastim-aafi

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

Product ID0069-0294_3a976868-6b9c-44b2-987a-3ec9cda3e7a1
NDC0069-0294
Product TypeHuman Prescription Drug
Proprietary NameNivestym
Generic NameFilgrastim-aafi
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2019-03-11
Marketing CategoryBLA / BLA
Application NumberBLA761080
Labeler NamePfizer Laboratories Div Pfizer 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 0069-0294-10

10 VIAL, SINGLE-DOSE in 1 CARTON (0069-0294-10) > 1.6 mL in 1 VIAL, SINGLE-DOSE (0069-0294-01)
Marketing Start Date2019-03-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0069-0294-10 [00069029410]

Nivestym INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA761080
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-03-11

NDC 0069-0294-01 [00069029401]

Nivestym INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA761080
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-03-11

Drug Details

Active Ingredients

IngredientStrength
FILGRASTIM480 ug/1.6mL

OpenFDA Data

SPL SET ID:d23ab39c-b6ec-41cf-a529-9dd2852c9d9a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2057205
  • 2057212
  • 2057200
  • 2057215
  • 2057216
  • 2057218
  • 2057219
  • 2057209
  • Pharmacological Class

    • Granulocyte Colony-Stimulating Factor [CS]
    • Granulocyte-Macrophage Colony-Stimulating Factor [CS]
    • Increased Myeloid Cell Production [PE]
    • Leukocyte Growth Factor [EPC]
    • 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 "Nivestym" or generic name "Filgrastim-aafi"

    NDCBrand NameGeneric Name
    0069-0291Nivestymfilgrastim-aafi
    0069-0292Nivestymfilgrastim-aafi
    0069-0293Nivestymfilgrastim-aafi
    0069-0294Nivestymfilgrastim-aafi

    Trademark Results [Nivestym]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NIVESTYM
    NIVESTYM
    86914849 5722625 Live/Registered
    Hospira, Inc.
    2016-02-22

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