NDC 0078-0860

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 ID: 0078-0860_0ef16a12-43a8-4956-b1c1-07877366d919
• NDC: 0078-0860
• Product Type: Human Prescription Drug
• Proprietary Name: KISQALI
• Generic Name: Ribociclib
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-03-13
• Marketing Category: NDA / NDA
• Application Number: NDA209092
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: RIBOCICLIB
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: Kinase Inhibitor [EPC],Kinase Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0078-0860-01

1 BLISTER PACK in 1 CARTON (0078-0860-01) > 21 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2017-03-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0860-01 [00078086001]

KISQALI TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA209092
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-03-13

Drug Details

Active Ingredients

Ingredient	Strength
RIBOCICLIB	200 mg/1

OpenFDA Data

• SPL SET ID: aaeaef94-f3f5-4367-8ea2-b181d7be2da8
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • TK8ERE8P56
• 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"

NDC	Brand Name	Generic Name
0078-0860	KISQALI	ribociclib
0078-0867	KISQALI	ribociclib
0078-0874	KISQALI	ribociclib