NDC 0003-3774

OPDIVO

Nivolumab

OPDIVO is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by E.r. Squibb & Sons, L.l.c.. The primary component is Nivolumab.

Product ID0003-3774_01929db8-1a98-404e-b4dd-0664e6c0c212
NDC0003-3774
Product TypeHuman Prescription Drug
Proprietary NameOPDIVO
Generic NameNivolumab
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2014-12-22
Marketing CategoryBLA / BLA
Application NumberBLA125554
Labeler NameE.R. Squibb & Sons, L.L.C.
Substance NameNIVOLUMAB
Active Ingredient Strength10 mg/mL
Pharm ClassesProgrammed Death Receptor-1 Blocking Antibody [EPC],Programmed Death Receptor-1-directed Antibody Interactions [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0003-3774-12

1 VIAL, SINGLE-DOSE in 1 CARTON (0003-3774-12) > 10 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2014-12-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0003-3774-12 [00003377412]

OPDIVO INJECTION
Marketing CategoryBLA
Application NumberBLA125554
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-12-22

Drug Details

Active Ingredients

IngredientStrength
NIVOLUMAB10 mg/mL

OpenFDA Data

SPL SET ID:f570b9c4-6846-4de2-abfa-4d0a4ae4e394
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1657192
  • 1657190
  • 1657196
  • 1657195
  • 1991412
  • 1991413
  • Pharmacological Class

    • Programmed Death Receptor-1 Blocking Antibody [EPC]
    • Programmed Death Receptor-1-directed Antibody Interactions [MoA]

    NDC Crossover Matching brand name "OPDIVO" or generic name "Nivolumab"

    NDCBrand NameGeneric Name
    0003-3734OPDIVOnivolumab
    0003-3756OPDIVOnivolumab
    0003-3772OPDIVOnivolumab
    0003-3774OPDIVOOPDIVO

    Trademark Results [OPDIVO]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    OPDIVO
    OPDIVO
    90069120 not registered Live/Pending
    Bristol-Myers Squibb Company
    2020-07-23
    OPDIVO
    OPDIVO
    87252648 not registered Live/Pending
    Bristol-Myers Squibb Company
    2016-11-30
    OPDIVO
    OPDIVO
    86174642 4914296 Live/Registered
    Bristol-Myers Squibb Company
    2014-01-24
    OPDIVO
    OPDIVO
    85764349 4548457 Live/Registered
    Bristol-Myers Squibb Company
    2012-10-26

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