KISQALI FEMARA CO-PACK

Product NDC: 0078-0916
11-digit product format: 000780916
Labeler code: 0078
Product ID: 0078-0916_774105bc-8258-481c-8883-f25f25166aea
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: letrozole and ribociclib
Dosage form: KIT
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA209935
Marketing category: NDA
Marketing start: 2017-05-04
Marketing end: 2026-08-31
NDC exclude flag: No
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
N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	LETROZOLE; RIBOCICLIB SUCCINATE	2.5MG;EQ 200MG BASE	TABLET / ORAL		RLD, RS	2017-05-04

Orange Book patents#

Current patent rows page 1 of 1 · 29 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209935-001	8324225	2028-06-17		Drug substance, Drug product	2017-05-19
N209935-001	8324225*PED	2028-12-17		Pediatric extension
N209935-001	9416136	2029-08-20	U-2505		2017-05-19
N209935-001	9416136	2029-08-20	U-3264		2017-05-19
N209935-001	9416136	2029-08-20	U-3998		2017-05-19
N209935-001	8962630	2029-12-09	U-2505		2017-05-19
N209935-001	8962630	2029-12-09	U-3264		2017-05-19
N209935-001	8962630	2029-12-09	U-3998		2017-05-19
N209935-001	9416136*PED	2030-02-20		Pediatric extension
N209935-001	8685980	2030-05-25		Drug substance, Drug product	2017-05-19
N209935-001	8962630*PED	2030-06-09		Pediatric extension
N209935-001	8685980*PED	2030-11-25		Pediatric extension
N209935-001	8415355	2031-03-13		Drug substance, Drug product	2017-05-19
N209935-001	8415355*PED	2031-09-13		Pediatric extension
N209935-001	9193732	2031-11-09		Drug substance, Drug product	2017-05-19
N209935-001	9868739	2031-11-09	U-2505		2018-06-05
N209935-001	9868739	2031-11-09	U-3264		2018-06-05
N209935-001	9868739	2031-11-09	U-3998		2018-06-05
N209935-001	9193732*PED	2032-05-09		Pediatric extension
N209935-001	9868739*PED	2032-05-09		Pediatric extension
N209935-001	12544380	2034-08-07	U-3264		2026-02-10
N209935-001	12544380	2034-08-07	U-3998		2026-02-10
N209935-001	12544380*PED	2035-02-07		Pediatric extension
N209935-001	10799506	2036-04-14		Drug product	2020-11-06
N209935-001	12064434	2036-04-14		Drug product	2024-09-13
N209935-001	12419894	2036-04-14		Drug product	2025-10-02
N209935-001	10799506*PED	2036-10-14		Pediatric extension
N209935-001	12064434*PED	2036-10-14		Pediatric extension
N209935-001	12419894*PED	2036-10-14		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N209935-001	I-951	2027-09-17
N209935-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG,N/A;N/A,EQ 200MG BASE	TABLET, TABLET / ORAL	RLD, RS	2017-05-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG,N/A;N/A,EQ 200MG BASE	TABLET, TABLET / ORAL	RLD, RS	2017-05-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG,N/A;N/A,EQ 200MG BASE	TABLET, TABLET / ORAL	RLD, RS	2017-05-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG,N/A;N/A,EQ 200MG BASE	TABLET, TABLET / ORAL	RLD, RS	2017-05-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG,N/A;N/A,EQ 200MG BASE	TABLET, TABLET / ORAL	RLD, RS	2017-05-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG,N/A;N/A,EQ 200MG BASE	TABLET, TABLET / ORAL	RLD, RS	2017-05-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG,N/A;N/A,EQ 200MG BASE	TABLET, TABLET / ORAL	RLD, RS	2017-05-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG,N/A;N/A,EQ 200MG BASE	TABLET, TABLET / ORAL	RLD, RS	2017-05-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 12 · 477 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	N209935-001	8324225	2028-06-17		Drug substance, Drug product	2017-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	9416136	2029-08-20	U-2505		2017-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	9416136	2029-08-20	U-3998		2017-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	9416136	2029-08-20	U-3264		2017-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	8962630	2029-12-09	U-2505		2017-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	8962630	2029-12-09	U-3998		2017-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	8962630	2029-12-09	U-3264		2017-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	8685980	2030-05-25		Drug substance, Drug product	2017-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	8415355	2031-03-13		Drug substance, Drug product	2017-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	9193732	2031-11-09		Drug substance, Drug product	2017-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	9868739	2031-11-09	U-3998		2018-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	9868739	2031-11-09	U-2505		2018-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	9868739	2031-11-09	U-3264		2018-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	12544380	2034-08-07	U-3264		2026-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	12544380	2034-08-07	U-3998		2026-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	10799506	2036-04-14		Drug product	2020-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	12064434	2036-04-14		Drug product	2024-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	12419894	2036-04-14		Drug product	2025-10-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	8324225	2028-06-17		Drug substance, Drug product	2017-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	9416136	2029-08-20	U-2505		2017-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	9416136	2029-08-20	U-3998		2017-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	9416136	2029-08-20	U-3264		2017-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	8962630	2029-12-09	U-2505		2017-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	8962630	2029-12-09	U-3998		2017-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	8962630	2029-12-09	U-3264		2017-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	8685980	2030-05-25		Drug substance, Drug product	2017-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	8415355	2031-03-13		Drug substance, Drug product	2017-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	9193732	2031-11-09		Drug substance, Drug product	2017-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	9868739	2031-11-09	U-3998		2018-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	9868739	2031-11-09	U-2505		2018-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	9868739	2031-11-09	U-3264		2018-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	10799506	2036-04-14		Drug product	2020-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	12064434	2036-04-14		Drug product	2024-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	12419894	2036-04-14		Drug product	2025-10-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209935-001	8324225	2028-06-17		Drug substance, Drug product	2017-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209935-001	9416136	2029-08-20	U-2505		2017-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209935-001	9416136	2029-08-20	U-3998		2017-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209935-001	9416136	2029-08-20	U-3264		2017-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209935-001	8962630	2029-12-09	U-2505		2017-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209935-001	8962630	2029-12-09	U-3998		2017-05-19	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 55 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209935-001	I-951	2027-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	I-951	2027-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209935-001	I-951	2027-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209935-001	I-951	2027-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209935-001	I-951	2027-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209935-001	NPP	2024-12-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209935-001	I-951	2027-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209935-001	NPP	2024-12-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209935-001	I-951	2027-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209935-001	NPP	2024-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209935-001	NPP	2024-12-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209935-001	I-951	2027-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209935-001	NPP	2024-12-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209935-001	I-951	2027-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209935-001	NPP	2024-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209935-001	NPP	2024-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209935-001	NPP	2024-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209935-001	NPP	2024-12-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209935-001	NCE	2022-03-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209935-001	NPP	2024-12-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209935-001	NCE	2022-03-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209935-001	NPP	2024-12-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209935-001	NCE	2022-03-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209935-001	NPP	2024-12-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209935-001	NCE	2022-03-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209935-001	NCE	2022-03-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209935-001	NPP	2024-12-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209935-001	NCE	2022-03-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209935-001	NCE	2022-03-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209935-001	NCE	2022-03-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209935-001	NCE	2022-03-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209935-001	NCE	2022-03-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209935-001	NCE	2022-03-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209935-001	NCE	2022-03-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209935-001	NCE	2022-03-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209935-001	NPP	2024-12-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209935-001	NPP	2024-12-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209935-001	NPP	2024-12-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209935-001	NPP	2024-12-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209935-001	NPP	2024-12-10	`9b2671bbb829…`

Additional Listing Data#

Finished product: Yes
Brand name base: KISQALI FEMARA CO-PACK

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
153124	Internal RxNorm lookup
200064	Internal RxNorm lookup
1873983	Internal RxNorm lookup
1873989	Internal RxNorm lookup
1923053	Internal RxNorm lookup
1923054	Internal RxNorm lookup
1923055	Internal RxNorm lookup
1923056	Internal RxNorm lookup
1923057	Internal RxNorm lookup
1923058	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
aa5e4446-19cd-4235-a382-5b48bf6c3b2f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d50ad188-a2a9-1aec-5d6c-f8612e9e5867	Product name	4	20190528
4f1e9b6f-5fe1-47c9-ab31-3c39ee923083	Product name	2	20170713
c68d7051-6d86-4f8e-92b8-c65801991631	Product name	1	20170713

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0078-0881-50	KISQALI FEMARA CO-PACK	28 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	28	2.5 mg	25
0078-0916-61	KISQALI FEMARA CO-PACK	1 in 1 KIT	KIT	1		25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0916-61	EA - Each	0078-0916	eade4143-69cd-49fb-ac90-b4c2cb098148	1	2017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0078-0916	KISQALI FEMARA CO-PACK (LETROZOLE AND RIBOCICLIB) KIT [NOVARTIS PHARMACEUTICALS CORPORATION]	23	Current NDC, Legacy NDC, 2 package rows	20250303_aa5e4446-19cd-4235-a382-5b48bf6c3b2f.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 FEMARA CO-PACK	LETROZOLE AND RIBOCICLIB	Novartis Pharmaceuticals Corporation	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209935 application number: NDA209935 ndc (product): 0078-0916

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1923054	{28 (letrozole 2.5 MG Oral Tablet [Femara]) / 21 (ribociclib 200 MG Oral Tablet [Kisqali]) } Pack [Kisqali Femara Co-Pack 200]	BPCK	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
1923056	{28 (letrozole 2.5 MG Oral Tablet [Femara]) / 42 (ribociclib 200 MG Oral Tablet [Kisqali]) } Pack [Kisqali Femara Co-Pack 400]	BPCK	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
1923058	{28 (letrozole 2.5 MG Oral Tablet [Femara]) / 63 (ribociclib 200 MG Oral Tablet [Kisqali]) } Pack [Kisqali Femara Co-Pack 600]	BPCK	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
1923053	{28 (letrozole 2.5 MG Oral Tablet) / 21 (ribociclib 200 MG Oral Tablet) } Pack	GPCK	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
1923055	{28 (letrozole 2.5 MG Oral Tablet) / 42 (ribociclib 200 MG Oral Tablet) } Pack	GPCK	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
1923057	{28 (letrozole 2.5 MG Oral Tablet) / 63 (ribociclib 200 MG Oral Tablet) } Pack	GPCK	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
153124	Femara 2.5 MG Oral Tablet	PSN	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
1923054	Kisqali 200 MG - Femara 2.5 MG Daily Dose Carton	PSN	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
1873989	Kisqali 200 MG Oral Tablet	PSN	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
1923056	Kisqali 400 MG - Femara 2.5 MG Daily Dose Carton	PSN	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
1923058	Kisqali 600 MG - Femara 2.5 MG Daily Dose Carton	PSN	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
200064	letrozole 2.5 MG Oral Tablet	PSN	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
1923053	ribociclib 200 MG / letrozole 2.5 MG Daily Dose Carton	PSN	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
1873983	ribociclib 200 MG Oral Tablet	PSN	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
1923055	ribociclib 400 MG / letrozole 2.5 MG Daily Dose Carton	PSN	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
1923057	ribociclib 600 MG / letrozole 2.5 MG Daily Dose Carton	PSN	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
153124	letrozole 2.5 MG Oral Tablet [Femara]	SBD	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
1873989	ribociclib 200 MG Oral Tablet [Kisqali]	SBD	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
200064	letrozole 2.5 MG Oral Tablet	SCD	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
1873983	ribociclib 200 MG Oral Tablet	SCD	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
153124	Femara 2.5 MG Oral Tablet	SY	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
1923054	Kisqali 200 MG - Femara 2.5 MG Daily Dose Carton	SY	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
1923054	Kisqali 200 MG (21) / Femara 2.5 MG (28) Daily Dose Carton	SY	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
1923056	Kisqali 200 MG (42) / Femara 2.5 MG (28) Daily Dose Carton	SY	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
1923058	Kisqali 200 MG (63) / Femara 2.5 MG (28) Daily Dose Carton	SY	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
1873989	Kisqali 200 MG (equivalent to ribociclib succinate 254.4 MG) Oral Tablet	SY	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
1873989	Kisqali 200 MG Oral Tablet	SY	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
1923056	Kisqali 400 MG - Femara 2.5 MG Daily Dose Carton	SY	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
1923058	Kisqali 600 MG - Femara 2.5 MG Daily Dose Carton	SY	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
1923053	letrozole 2.5 MG (28) / ribociclib 200 MG (21) Pack	SY	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
1923055	letrozole 2.5 MG (28) / ribociclib 200 MG (42) Pack	SY	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
1923057	letrozole 2.5 MG (28) / ribociclib 200 MG (63) Pack	SY	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
1923057	letrozole 2.5 MG / ribociclib 600 MG Daily Dose Carton	SY	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25
1873983	ribociclib 200 MG (equivalent to ribociclib succinate 254.4 MG) Oral Tablet	SY	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	25

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0881-50	00078088150	28 in 1 BOTTLE, PLASTIC						Historical
0078-0916-61	00078091661	1 KIT in 1 KIT (0078-0916-61) * 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0881-50) * 14 TABLET in 1 BLISTER PACK (0078-0895-14)	1 kit	2017-05-04	2026-08-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
KISQALI FEMARA CO-PACK	Novartis Pharmaceuticals Corporation	2026-07-01	HUMAN PRESCRIPTION DRUG LABEL	26