NDC 0074-0561

Venclexta

Venetoclax

Venclexta is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Abbvie Inc.. The primary component is Venetoclax.

Product ID0074-0561_2284c7ad-cd64-4d4c-0355-1e21172bba43
NDC0074-0561
Product TypeHuman Prescription Drug
Proprietary NameVenclexta
Generic NameVenetoclax
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-04-11
Marketing CategoryNDA / NDA
Application NumberNDA208573
Labeler NameAbbVie Inc.
Substance NameVENETOCLAX
Active Ingredient Strength10 mg/1
Pharm ClassesBCL-2 Inhibitor [EPC],Increased Cellular Death [PE],P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0074-0561-11

1 BLISTER PACK in 1 CARTON (0074-0561-11) > 2 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2016-04-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0074-0561-11 [00074056111]

Venclexta TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA208573
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-04-11

NDC 0074-0561-14 [00074056114]

Venclexta TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA208573
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-04-11

Drug Details

Active Ingredients

IngredientStrength
VENETOCLAX10 mg/1

OpenFDA Data

SPL SET ID:b118a40d-6b56-cee3-10f6-ded821a97018
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1747579
  • 1747580
  • 1747572
  • 1747567
  • 1747561
  • 1747577
  • 1747574
  • 1747575
  • UPC Code
  • 0300740576224
  • Pharmacological Class

    • BCL-2 Inhibitor [EPC]
    • Increased Cellular Death [PE]
    • P-Glycoprotein Inhibitors [MoA]

    NDC Crossover Matching brand name "Venclexta" or generic name "Venetoclax"

    NDCBrand NameGeneric Name
    0074-0561VenclextaVenetoclax
    0074-0566VenclextaVenetoclax
    0074-0576VenclextaVenetoclax
    0074-0579VenclextaVenetoclax

    Trademark Results [Venclexta]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    VENCLEXTA
    VENCLEXTA
    86855625 5079634 Live/Registered
    AbbVie Inc.
    2015-12-21
    VENCLEXTA
    VENCLEXTA
    86560752 5078740 Live/Registered
    AbbVie Inc.
    2015-03-11

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