FDA.reportPublic FDA data

KISQALI

Product NDC
0078-0874
11-digit product format
000780874
Labeler code
0078
Product ID
0078-0874_0f5f8b14-d798-49dd-bfbf-e9643c545c93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ribociclib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA209092
Marketing category
NDA
Marketing start
2017-03-13
Substance
RIBOCICLIB SUCCINATE
Active strength
200 mg/1
Pharmacologic classes
Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
KISQALI
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIBOCICLIB SUCCINATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBG7HLX2919
Rxcui1873983, 1873989, 1873990, 1873991, 1873992, 1873993, 1873994, 1873995

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4f1e9b6f-5fe1-47c9-ab31-3c39ee923083Product name220170713
c68d7051-6d86-4f8e-92b8-c65801991631Product name120170713

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0874-21KISQALI21 in 1 BLISTER PACKTABLET, FILM COATED2127
0078-0874-63KISQALI3 in 1 CARTONTABLET, FILM COATED327

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0874-21EA - Each0078-0874d10f5b89-3c66-4045-8ff7-d5373c734db912017-04-05
0078-0874-63EA - Each0078-0874b4359d08-351d-43ce-a7f5-d15c40214eb712017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0874KISQALI (RIBOCICLIB) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]24Current NDC, Legacy NDC, 2 package rows20250303_aaeaef94-f3f5-4367-8ea2-b181d7be2da8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1873991{21 (ribociclib 200 MG Oral Tablet [Kisqali]) } Pack [Kisqali 200 MG Daily Dose Carton]BPCKaaeaef94-f3f5-4367-8ea2-b181d7be2da827
1873993{42 (ribociclib 200 MG Oral Tablet [Kisqali]) } Pack [Kisqali 400 MG Daily Dose Carton]BPCKaaeaef94-f3f5-4367-8ea2-b181d7be2da827
1873995{63 (ribociclib 200 MG Oral Tablet [Kisqali]) } Pack [Kisqali 600 MG Daily Dose Carton]BPCKaaeaef94-f3f5-4367-8ea2-b181d7be2da827
1873990{21 (ribociclib 200 MG Oral Tablet) } PackGPCKaaeaef94-f3f5-4367-8ea2-b181d7be2da827
1873992{42 (ribociclib 200 MG Oral Tablet) } PackGPCKaaeaef94-f3f5-4367-8ea2-b181d7be2da827
1873994{63 (ribociclib 200 MG Oral Tablet) } PackGPCKaaeaef94-f3f5-4367-8ea2-b181d7be2da827
1873991Kisqali 200 MG Daily Dose Carton PackPSNaaeaef94-f3f5-4367-8ea2-b181d7be2da827
1873989Kisqali 200 MG Oral TabletPSNaaeaef94-f3f5-4367-8ea2-b181d7be2da827
1873993Kisqali 400 MG Daily Dose Carton PackPSNaaeaef94-f3f5-4367-8ea2-b181d7be2da827
1873995Kisqali 600 MG Daily Dose Carton PackPSNaaeaef94-f3f5-4367-8ea2-b181d7be2da827
1873990ribociclib 200 MG Daily Dose, 200 MG Oral Tablet 21 Count PackPSNaaeaef94-f3f5-4367-8ea2-b181d7be2da827
1873983ribociclib 200 MG Oral TabletPSNaaeaef94-f3f5-4367-8ea2-b181d7be2da827
1873992ribociclib 400 MG Daily Dose, 200 MG Oral Tablet 42 Count PackPSNaaeaef94-f3f5-4367-8ea2-b181d7be2da827
1873994ribociclib 600 MG Daily Dose, 200 MG Oral Tablet 63 Count PackPSNaaeaef94-f3f5-4367-8ea2-b181d7be2da827
1873989ribociclib 200 MG Oral Tablet [Kisqali]SBDaaeaef94-f3f5-4367-8ea2-b181d7be2da827
1873983ribociclib 200 MG Oral TabletSCDaaeaef94-f3f5-4367-8ea2-b181d7be2da827
1873989Kisqali 200 MG (equivalent to ribociclib succinate 254.4 MG) Oral TabletSYaaeaef94-f3f5-4367-8ea2-b181d7be2da827
1873991Kisqali 200 MG Daily Dose Carton PackSYaaeaef94-f3f5-4367-8ea2-b181d7be2da827
1873989Kisqali 200 MG Oral TabletSYaaeaef94-f3f5-4367-8ea2-b181d7be2da827
1873993Kisqali 400 MG Daily Dose Carton PackSYaaeaef94-f3f5-4367-8ea2-b181d7be2da827
1873995Kisqali 600 MG Daily Dose Carton PackSYaaeaef94-f3f5-4367-8ea2-b181d7be2da827
1873983ribociclib 200 MG (equivalent to ribociclib succinate 254.4 MG) Oral TabletSYaaeaef94-f3f5-4367-8ea2-b181d7be2da827
1873990ribociclib 200 MG Daily Dose Carton Pack, 1 Blister Card, 21 Tablets EachSYaaeaef94-f3f5-4367-8ea2-b181d7be2da827
1873992ribociclib 400 MG Daily Dose Carton Pack, 3 Blister Cards, 14 Tablets EachSYaaeaef94-f3f5-4367-8ea2-b181d7be2da827
1873994ribociclib 600 MG Daily Dose Carton Pack, 3 Blister Cards, 21 Tablets EachSYaaeaef94-f3f5-4367-8ea2-b181d7be2da827

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0874-210007808742121 in 1 BLISTER PACKHistorical
0078-0874-63000780874633 BLISTER PACK in 1 CARTON (0078-0874-63) / 21 TABLET, FILM COATED in 1 BLISTER PACK (0078-0874-21) 3 blister pack2017-03-130000-00-00NoNoCurrent