NDC 0078-0867

KISQALI

Ribociclib

KISQALI is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Ribociclib.

Product ID0078-0867_0ef16a12-43a8-4956-b1c1-07877366d919
NDC0078-0867
Product TypeHuman Prescription Drug
Proprietary NameKISQALI
Generic NameRibociclib
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-03-13
Marketing CategoryNDA / NDA
Application NumberNDA209092
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameRIBOCICLIB
Active Ingredient Strength200 mg/1
Pharm ClassesKinase Inhibitor [EPC],Kinase Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0078-0867-42

3 BLISTER PACK in 1 CARTON (0078-0867-42) > 14 TABLET, FILM COATED in 1 BLISTER PACK (0078-0867-14)
Marketing Start Date2017-03-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0867-14 [00078086714]

KISQALI TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA209092
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-03-13

NDC 0078-0867-42 [00078086742]

KISQALI TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA209092
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-03-13

Drug Details

Active Ingredients

IngredientStrength
RIBOCICLIB200 mg/1

OpenFDA Data

SPL SET ID:aaeaef94-f3f5-4367-8ea2-b181d7be2da8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1873992
  • 1873993
  • 1873990
  • 1873991
  • 1873994
  • 1873983
  • 1873995
  • 1873989
  • Pharmacological Class

    • Kinase Inhibitor [EPC]
    • Kinase Inhibitors [MoA]
    • Cytochrome P450 3A Inhibitors [MoA]

    NDC Crossover Matching brand name "KISQALI" or generic name "Ribociclib"

    NDCBrand NameGeneric Name
    0078-0860KISQALIribociclib
    0078-0867KISQALIribociclib
    0078-0874KISQALIribociclib

    Trademark Results [KISQALI]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    KISQALI
    KISQALI
    79156360 4820261 Live/Registered
    NOVARTIS AG
    2014-10-02

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