NDC 0003-2327

YERVOY

Ipilimumab

YERVOY 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 Ipilimumab.

Product ID0003-2327_18f077d2-f5e7-422b-86be-0640c317b8ed
NDC0003-2327
Product TypeHuman Prescription Drug
Proprietary NameYERVOY
Generic NameIpilimumab
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2011-03-25
Marketing CategoryBLA / BLA
Application NumberBLA125377
Labeler NameE.R. Squibb & Sons, L.L.C.
Substance NameIPILIMUMAB
Active Ingredient Strength5 mg/mL
Pharm ClassesCTLA-4-directed Blocking Antibody [EPC],CTLA-4-directed Antibody Interactions [MoA],Increased T Lymphocyte Activation [PE]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0003-2327-11

1 VIAL, SINGLE-USE in 1 CARTON (0003-2327-11) > 10 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2011-03-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0003-2327-11 [00003232711]

YERVOY INJECTION
Marketing CategoryBLA
Application NumberBLA125377
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-03-25

Drug Details

Active Ingredients

IngredientStrength
IPILIMUMAB5 mg/mL

OpenFDA Data

SPL SET ID:2265ef30-253e-11df-8a39-0800200c9a66
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1657005
  • 1657007
  • 1657013
  • 1657012
  • Pharmacological Class

    • CTLA-4-directed Blocking Antibody [EPC]
    • CTLA-4-directed Antibody Interactions [MoA]
    • Increased T Lymphocyte Activation [PE]

    NDC Crossover Matching brand name "YERVOY" or generic name "Ipilimumab"

    NDCBrand NameGeneric Name
    0003-2327YERVOYipilimumab
    0003-2328YERVOYipilimumab

    Trademark Results [YERVOY]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    YERVOY
    YERVOY
    86328155 4798065 Live/Registered
    Bristol-Myers Squibb Company
    2014-07-03
    YERVOY
    YERVOY
    85709885 4518533 Live/Registered
    Bristol-Myers Squibb Company
    2012-08-22
    YERVOY
    YERVOY
    85075624 not registered Dead/Abandoned
    Bristol-Myers Squibb Company
    2010-07-01
    YERVOY
    YERVOY
    77750782 3982015 Live/Registered
    Bristol-Myers Squibb Company
    2009-06-03

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