kisqali

Generic: ribociclib

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name kisqali
Generic Name ribociclib
Labeler novartis pharmaceuticals corporation
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ribociclib succinate 200 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0874
Product ID 0078-0874_0f5f8b14-d798-49dd-bfbf-e9643c545c93
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209092
Listing Expiration 2026-12-31
Marketing Start 2017-03-13

Pharmacologic Class

Classes
cytochrome p450 3a inhibitors [moa] kinase inhibitor [epc] kinase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00780874
Hyphenated Format 0078-0874

Supplemental Identifiers

RxCUI
1873983 1873989 1873990 1873991 1873992 1873993 1873994 1873995
UNII
BG7HLX2919

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name kisqali (source: ndc)
Generic Name ribociclib (source: ndc)
Application Number NDA209092 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (0078-0874-63) / 21 TABLET, FILM COATED in 1 BLISTER PACK (0078-0874-21)
source: ndc

Packages (1)

0078-0874-63 3 BLISTER PACK in 1 CARTON (0078-0874-63) / 21 TABLET, FILM COATED in 1 BLISTER PACK (0078-0874-21)

Ingredients (1)

ribociclib succinate (200 mg/1)

Linked Drug Pages (1)

KISQALI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0f5f8b14-d798-49dd-bfbf-e9643c545c93", "openfda": {"unii": ["BG7HLX2919"], "rxcui": ["1873983", "1873989", "1873990", "1873991", "1873992", "1873993", "1873994", "1873995"], "spl_set_id": ["aaeaef94-f3f5-4367-8ea2-b181d7be2da8"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (0078-0874-63)  / 21 TABLET, FILM COATED in 1 BLISTER PACK (0078-0874-21)", "package_ndc": "0078-0874-63", "marketing_start_date": "20170313"}], "brand_name": "KISQALI", "product_id": "0078-0874_0f5f8b14-d798-49dd-bfbf-e9643c545c93", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 3A Inhibitors [MoA]", "Kinase Inhibitor [EPC]", "Kinase Inhibitors [MoA]"], "product_ndc": "0078-0874", "generic_name": "ribociclib", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KISQALI", "active_ingredients": [{"name": "RIBOCICLIB SUCCINATE", "strength": "200 mg/1"}], "application_number": "NDA209092", "marketing_category": "NDA", "marketing_start_date": "20170313", "listing_expiration_date": "20261231"}