NDC 0169-7901

REBINYN

(coagulation Factor Ix (recombinant), Glycopegylated)

REBINYN is a Kit in the Human Prescription Drug category. It is labeled and distributed by Novo Nordisk. The primary component is .

Product ID0169-7901_2df3f725-b51f-4984-976f-e3069d69210f
NDC0169-7901
Product TypeHuman Prescription Drug
Proprietary NameREBINYN
Generic Name(coagulation Factor Ix (recombinant), Glycopegylated)
Dosage FormKit
Marketing Start Date2017-12-01
Marketing CategoryBLA / BLA
Application NumberBLA125611
Labeler NameNovo Nordisk
Active Ingredient Strength0
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0169-7901-01

1 KIT in 1 KIT (0169-7901-01) * 4 mL in 1 VIAL, GLASS (0169-7911-90) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98) * 4 mL in 1 VIAL, GLASS (0169-7911-11)
Marketing Start Date2017-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0169-7901-01 [00169790101]

REBINYN KIT
Marketing CategoryBLA
Application NumberBLA125611
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-12-01

Drug Details

OpenFDA Data

SPL SET ID:0ea37235-35fd-410d-b8c4-40ba15fe1294
Manufacturer
RxNorm Concept Unique ID - RxCUI
  • 1990857
  • 1990862
  • NDC Crossover Matching brand name "REBINYN" or generic name "(coagulation Factor Ix (recombinant), Glycopegylated)"

    NDCBrand NameGeneric Name
    0169-7901REBINYN(Coagulation Factor IX (Recombinant), GlycoPEGylated)
    0169-7902REBINYN(Coagulation Factor IX (Recombinant), GlycoPEGylated)
    0169-7903REBINYN(Coagulation Factor IX (Recombinant), GlycoPEGylated)
    0169-7905REBINYN(Coagulation Factor IX (Recombinant), GlycoPEGylated)

    Trademark Results [REBINYN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    REBINYN
    REBINYN
    79156280 4714544 Live/Registered
    Novo Nordisk Health Care AG
    2014-07-14

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