KISQALI FEMARA CO-PACK

Product NDC: 0078-0923
11-digit product format: 000780923
Labeler code: 0078
Product ID: 0078-0923_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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0078-0923		D	Discontinued by firm		2026-09-14
excluded package	package	0078-0923	0078-0923-61	D	Discontinued by firm		2026-09-14

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 4 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
N209935-001	M-14	2029-07-01
N209935-001	PED	2030-01-01

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 535 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209935-001	8324225	2028-06-17		Drug substance, Drug product	2017-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	8324225*PED	2028-12-17		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	9416136	2029-08-20	U-2505		2017-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	9416136	2029-08-20	U-3998		2017-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	9416136	2029-08-20	U-3264		2017-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	8962630	2029-12-09	U-2505		2017-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	8962630	2029-12-09	U-3998		2017-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	8962630	2029-12-09	U-3264		2017-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	9416136*PED	2030-02-20		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	8685980	2030-05-25		Drug substance, Drug product	2017-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	8962630*PED	2030-06-09		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	8685980*PED	2030-11-25		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	8415355	2031-03-13		Drug substance, Drug product	2017-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	8415355*PED	2031-09-13		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	9193732	2031-11-09		Drug substance, Drug product	2017-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	9868739	2031-11-09	U-3998		2018-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	9868739	2031-11-09	U-2505		2018-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	9868739	2031-11-09	U-3264		2018-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	9193732*PED	2032-05-09		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	9868739*PED	2032-05-09		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	12544380	2034-08-07	U-3264		2026-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	12544380	2034-08-07	U-3998		2026-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	12544380*PED	2035-02-07		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	10799506	2036-04-14		Drug product	2020-11-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	12064434	2036-04-14		Drug product	2024-09-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	12419894	2036-04-14		Drug product	2025-10-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	10799506*PED	2036-10-14		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	12064434*PED	2036-10-14		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	12419894*PED	2036-10-14		Pediatric extension		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209935-001	8324225	2028-06-17		Drug substance, Drug product	2017-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209935-001	8324225*PED	2028-12-17		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209935-001	9416136	2029-08-20	U-2505		2017-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209935-001	9416136	2029-08-20	U-3998		2017-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209935-001	9416136	2029-08-20	U-3264		2017-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209935-001	8962630	2029-12-09	U-2505		2017-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209935-001	8962630	2029-12-09	U-3998		2017-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209935-001	8962630	2029-12-09	U-3264		2017-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209935-001	9416136*PED	2030-02-20		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209935-001	8685980	2030-05-25		Drug substance, Drug product	2017-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209935-001	8962630*PED	2030-06-09		Pediatric extension		`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 61 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N209935-001	I-951	2027-09-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	PED	2028-03-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	M-14	2029-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	PED	2030-01-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209935-001	I-951	2027-09-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209935-001	PED	2028-03-17	`caaa826d4ba7…`
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…`

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
0078-0923-61	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
0078-0923-61	EA - Each	0078-0923	c9815e59-1057-4a40-96ba-72cef175b4b3	1	2017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0078-0923	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

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
0078-0923-61	00078092361	1 KIT in 1 KIT (0078-0923-61) * 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0881-50) * 21 TABLET in 1 BLISTER PACK (0078-0902-21)	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