Home NDC 0078-0860 KISQALI
Product NDC 0078-0860
11-digit product format 000780860
Labeler code 0078
Product ID 0078-0860_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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N209092-001 KISQALI RIBOCICLIB SUCCINATE EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13
Orange Book patents# Current patent rows page 1 of 1 · 43 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N209092-001 I-950 2027-09-17 N209092-001 PED 2028-03-17
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N209092-001 KISQALI EQ 200MG BASE TABLET / ORAL RLD, RS 2017-03-13 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 22 · 855 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N209092-001 8324225 2028-06-17 Drug substance, Drug product 2017-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 9416136 2029-08-20 U-2355 2017-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 9416136 2029-08-20 U-2356 2017-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 9416136 2029-08-20 U-1981 2017-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 9416136 2029-08-20 U-3999 2017-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 9416136 2029-08-20 U-3266 2017-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 9416136 2029-08-20 U-3265 2017-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 9416136 2029-08-20 U-3975 2017-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 8962630 2029-12-09 U-1981 2017-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 8962630 2029-12-09 U-2356 2017-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 8962630 2029-12-09 U-2355 2017-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 8962630 2029-12-09 U-3999 2017-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 8962630 2029-12-09 U-3265 2017-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 8962630 2029-12-09 U-3266 2017-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 8962630 2029-12-09 U-3975 2017-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 8685980 2030-05-25 Drug substance, Drug product 2017-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 8415355 2031-03-13 Drug substance, Drug product 2017-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 9193732 2031-11-09 Drug substance, Drug product 2017-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 9868739 2031-11-09 U-2355 2018-06-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 9868739 2031-11-09 U-2356 2018-06-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 9868739 2031-11-09 U-3999 2018-06-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 9868739 2031-11-09 U-1981 2018-06-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 9868739 2031-11-09 U-3975 2018-06-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 9868739 2031-11-09 U-3265 2018-06-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 9868739 2031-11-09 U-3266 2018-06-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 12544379 2034-08-07 U-3975 2026-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 12544380 2034-08-07 U-4404 2026-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 12544380 2034-08-07 U-4405 2026-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 10799506 2036-04-14 Drug product 2020-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 12064434 2036-04-14 Drug product 2024-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209092-001 12419894 2036-04-14 Drug product 2025-10-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209092-001 8324225 2028-06-17 Drug substance, Drug product 2017-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209092-001 9416136 2029-08-20 U-2355 2017-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209092-001 9416136 2029-08-20 U-2356 2017-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209092-001 9416136 2029-08-20 U-1981 2017-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209092-001 9416136 2029-08-20 U-3999 2017-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209092-001 9416136 2029-08-20 U-3266 2017-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209092-001 9416136 2029-08-20 U-3265 2017-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209092-001 9416136 2029-08-20 U-3975 2017-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209092-001 8962630 2029-12-09 U-1981 2017-04-03 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 73 observed states.
Additional Listing Data#
Finished product Yes
Brand name base KISQALI
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RIBOCICLIB SUCCINATE 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BG7HLX2919 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1873983 Internal RxNorm lookup 1873989 Internal RxNorm lookup 1873990 Internal RxNorm lookup 1873991 Internal RxNorm lookup 1873992 Internal RxNorm lookup 1873993 Internal RxNorm lookup 1873994 Internal RxNorm lookup 1873995 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0078-0860-01 KISQALI 1 in 1 CARTON TABLET, FILM COATED 1 27 0078-0860-01 KISQALI 21 in 1 BLISTER PACK TABLET, FILM COATED 21 27
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0860 KISQALI (RIBOCICLIB) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 24 Current NDC, Legacy NDC, 2 package rows 20250303_aaeaef94-f3f5-4367-8ea2-b181d7be2da8.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join KISQALI RIBOCICLIB Novartis Pharmaceuticals Corporation aaeaef94-f3f5-4367-8ea2-b181d7be2da8 2026-07-01 Warnings, Adverse reactions Exact identifier application applno (NDA): 209092 application number: NDA209092 ndc (product): 0078-0860
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1873991 {21 (ribociclib 200 MG Oral Tablet [Kisqali]) } Pack [Kisqali 200 MG Daily Dose Carton] BPCK aaeaef94-f3f5-4367-8ea2-b181d7be2da8 27 1873993 {42 (ribociclib 200 MG Oral Tablet [Kisqali]) } Pack [Kisqali 400 MG Daily Dose Carton] BPCK aaeaef94-f3f5-4367-8ea2-b181d7be2da8 27 1873995 {63 (ribociclib 200 MG Oral Tablet [Kisqali]) } Pack [Kisqali 600 MG Daily Dose Carton] BPCK aaeaef94-f3f5-4367-8ea2-b181d7be2da8 27 1873990 {21 (ribociclib 200 MG Oral Tablet) } Pack GPCK aaeaef94-f3f5-4367-8ea2-b181d7be2da8 27 1873992 {42 (ribociclib 200 MG Oral Tablet) } Pack GPCK aaeaef94-f3f5-4367-8ea2-b181d7be2da8 27 1873994 {63 (ribociclib 200 MG Oral Tablet) } Pack GPCK aaeaef94-f3f5-4367-8ea2-b181d7be2da8 27 1873991 Kisqali 200 MG Daily Dose Carton Pack PSN aaeaef94-f3f5-4367-8ea2-b181d7be2da8 27 1873989 Kisqali 200 MG Oral Tablet PSN aaeaef94-f3f5-4367-8ea2-b181d7be2da8 27 1873993 Kisqali 400 MG Daily Dose Carton Pack PSN aaeaef94-f3f5-4367-8ea2-b181d7be2da8 27 1873995 Kisqali 600 MG Daily Dose Carton Pack PSN aaeaef94-f3f5-4367-8ea2-b181d7be2da8 27 1873990 ribociclib 200 MG Daily Dose, 200 MG Oral Tablet 21 Count Pack PSN aaeaef94-f3f5-4367-8ea2-b181d7be2da8 27 1873983 ribociclib 200 MG Oral Tablet PSN aaeaef94-f3f5-4367-8ea2-b181d7be2da8 27 1873992 ribociclib 400 MG Daily Dose, 200 MG Oral Tablet 42 Count Pack PSN aaeaef94-f3f5-4367-8ea2-b181d7be2da8 27 1873994 ribociclib 600 MG Daily Dose, 200 MG Oral Tablet 63 Count Pack PSN aaeaef94-f3f5-4367-8ea2-b181d7be2da8 27 1873989 ribociclib 200 MG Oral Tablet [Kisqali] SBD aaeaef94-f3f5-4367-8ea2-b181d7be2da8 27 1873983 ribociclib 200 MG Oral Tablet SCD aaeaef94-f3f5-4367-8ea2-b181d7be2da8 27 1873989 Kisqali 200 MG (equivalent to ribociclib succinate 254.4 MG) Oral Tablet SY aaeaef94-f3f5-4367-8ea2-b181d7be2da8 27 1873991 Kisqali 200 MG Daily Dose Carton Pack SY aaeaef94-f3f5-4367-8ea2-b181d7be2da8 27 1873989 Kisqali 200 MG Oral Tablet SY aaeaef94-f3f5-4367-8ea2-b181d7be2da8 27 1873993 Kisqali 400 MG Daily Dose Carton Pack SY aaeaef94-f3f5-4367-8ea2-b181d7be2da8 27 1873995 Kisqali 600 MG Daily Dose Carton Pack SY aaeaef94-f3f5-4367-8ea2-b181d7be2da8 27 1873983 ribociclib 200 MG (equivalent to ribociclib succinate 254.4 MG) Oral Tablet SY aaeaef94-f3f5-4367-8ea2-b181d7be2da8 27 1873990 ribociclib 200 MG Daily Dose Carton Pack, 1 Blister Card, 21 Tablets Each SY aaeaef94-f3f5-4367-8ea2-b181d7be2da8 27 1873992 ribociclib 400 MG Daily Dose Carton Pack, 3 Blister Cards, 14 Tablets Each SY aaeaef94-f3f5-4367-8ea2-b181d7be2da8 27 1873994 ribociclib 600 MG Daily Dose Carton Pack, 3 Blister Cards, 21 Tablets Each SY aaeaef94-f3f5-4367-8ea2-b181d7be2da8 27
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0078-0860-01 00078086001 1 BLISTER PACK in 1 CARTON (0078-0860-01) / 21 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2017-03-13 0000-00-00 No No Current