SCEMBLIX

Product NDC: 0078-1091
11-digit product format: 000781091
Labeler code: 0078
Product ID: 0078-1091_e187165a-eb84-4ee5-98b8-d4e777ec7b4a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: asciminib
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA215358
Marketing category: NDA
Marketing start: 2021-10-29
Substance: ASCIMINIB HYDROCHLORIDE
Active strength: 20 mg/1
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N215358-001	SCEMBLIX	ASCIMINIB HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	RLD	2021-10-29
N215358-002	SCEMBLIX	ASCIMINIB HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	RLD	2021-10-29
N215358-003	SCEMBLIX	ASCIMINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2024-04-18

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215358-001	8829195	2035-10-29	U-1374	Drug substance	2021-11-19
N215358-001	11407735	2040-05-14		Drug substance	2022-08-23
N215358-001	12252478	2040-05-14		Drug product	2025-04-04
N215358-001	12252479	2040-05-17	U-1374		2025-04-04
N215358-002	8829195	2035-10-29	U-1374	Drug substance	2021-11-19
N215358-002	11407735	2040-05-14		Drug substance	2022-08-23
N215358-002	12252478	2040-05-14		Drug product	2025-04-04
N215358-002	12252479	2040-05-17	U-1374		2025-04-04
N215358-003	8829195	2035-10-29	U-1374	Drug substance	2024-05-10
N215358-003	11407735	2040-05-14		Drug substance	2024-05-10
N215358-003	12252478	2040-05-14		Drug product	2025-04-04
N215358-003	12252479	2040-05-17	U-1374		2025-04-04

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 19 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215358-001	NCE	2026-10-29
N215358-001	I-953	2027-10-29
N215358-001	I-954	2027-10-29
N215358-001	M-318	2028-10-02
N215358-001	ODE-381	2028-10-29
N215358-001	ODE-382	2028-10-29
N215358-001	ODE-499	2031-10-29
N215358-001	ODE-500	2031-10-29
N215358-002	NCE	2026-10-29
N215358-002	I-953	2027-10-29
N215358-002	I-954	2027-10-29
N215358-002	M-318	2028-10-02
N215358-002	ODE-381	2028-10-29
N215358-002	ODE-382	2028-10-29
N215358-002	ODE-499	2031-10-29
N215358-002	ODE-500	2031-10-29
N215358-003	NCE	2026-10-29
N215358-003	M-318	2028-10-02
N215358-003	ODE*	2028-10-29

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 3 · 81 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	N215358-001	SCEMBLIX	EQ 20MG BASE	TABLET / ORAL	RLD	2021-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-002	SCEMBLIX	EQ 40MG BASE	TABLET / ORAL	RLD	2021-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-003	SCEMBLIX	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2024-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-001	SCEMBLIX	EQ 20MG BASE	TABLET / ORAL	RLD	2021-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-002	SCEMBLIX	EQ 40MG BASE	TABLET / ORAL	RLD, RS	2021-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-003	SCEMBLIX	EQ 100MG BASE	TABLET / ORAL	RLD	2024-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215358-001	SCEMBLIX	EQ 20MG BASE	TABLET / ORAL	RLD	2021-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215358-002	SCEMBLIX	EQ 40MG BASE	TABLET / ORAL	RLD, RS	2021-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215358-003	SCEMBLIX	EQ 100MG BASE	TABLET / ORAL	RLD	2024-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215358-001	SCEMBLIX	EQ 20MG BASE	TABLET / ORAL	RLD	2021-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215358-002	SCEMBLIX	EQ 40MG BASE	TABLET / ORAL	RLD, RS	2021-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215358-003	SCEMBLIX	EQ 100MG BASE	TABLET / ORAL	RLD	2024-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215358-001	SCEMBLIX	EQ 20MG BASE	TABLET / ORAL	RLD	2021-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215358-002	SCEMBLIX	EQ 40MG BASE	TABLET / ORAL	RLD, RS	2021-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215358-003	SCEMBLIX	EQ 100MG BASE	TABLET / ORAL	RLD	2024-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215358-001	SCEMBLIX	EQ 20MG BASE	TABLET / ORAL	RLD	2021-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215358-002	SCEMBLIX	EQ 40MG BASE	TABLET / ORAL	RLD, RS	2021-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215358-003	SCEMBLIX	EQ 100MG BASE	TABLET / ORAL	RLD	2024-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215358-001	SCEMBLIX	EQ 20MG BASE	TABLET / ORAL	RLD	2021-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215358-002	SCEMBLIX	EQ 40MG BASE	TABLET / ORAL	RLD, RS	2021-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215358-003	SCEMBLIX	EQ 100MG BASE	TABLET / ORAL	RLD	2024-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215358-001	SCEMBLIX	EQ 20MG BASE	TABLET / ORAL	RLD	2021-10-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215358-002	SCEMBLIX	EQ 40MG BASE	TABLET / ORAL	RLD, RS	2021-10-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215358-003	SCEMBLIX	EQ 100MG BASE	TABLET / ORAL	RLD	2024-04-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215358-001	SCEMBLIX	EQ 20MG BASE	TABLET / ORAL	RLD	2021-10-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215358-002	SCEMBLIX	EQ 40MG BASE	TABLET / ORAL	RLD, RS	2021-10-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215358-003	SCEMBLIX	EQ 100MG BASE	TABLET / ORAL	RLD	2024-04-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215358-001	SCEMBLIX	EQ 20MG BASE	TABLET / ORAL	RLD	2021-10-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215358-002	SCEMBLIX	EQ 40MG BASE	TABLET / ORAL	RLD, RS	2021-10-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215358-003	SCEMBLIX	EQ 100MG BASE	TABLET / ORAL	RLD	2024-04-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215358-001	SCEMBLIX	EQ 20MG BASE	TABLET / ORAL	RLD	2021-10-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215358-002	SCEMBLIX	EQ 40MG BASE	TABLET / ORAL	RLD, RS	2021-10-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215358-003	SCEMBLIX	EQ 100MG BASE	TABLET / ORAL	RLD	2024-04-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215358-001	SCEMBLIX	EQ 20MG BASE	TABLET / ORAL	RLD	2021-10-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215358-002	SCEMBLIX	EQ 40MG BASE	TABLET / ORAL	RLD, RS	2021-10-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215358-003	SCEMBLIX	EQ 100MG BASE	TABLET / ORAL	RLD	2024-04-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215358-001	SCEMBLIX	EQ 20MG BASE	TABLET / ORAL	RLD	2021-10-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215358-002	SCEMBLIX	EQ 40MG BASE	TABLET / ORAL	RLD, RS	2021-10-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215358-003	SCEMBLIX	EQ 100MG BASE	TABLET / ORAL	RLD	2024-04-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215358-001	SCEMBLIX	EQ 20MG BASE	TABLET / ORAL	RLD	2021-10-29	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 172 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	N215358-001	8829195	2035-10-29	U-1374	Drug substance	2021-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-001	11407735	2040-05-14		Drug substance	2022-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-001	12252478	2040-05-14		Drug product	2025-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-001	12252479	2040-05-17	U-1374		2025-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-002	8829195	2035-10-29	U-1374	Drug substance	2021-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-002	11407735	2040-05-14		Drug substance	2022-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-002	12252478	2040-05-14		Drug product	2025-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-002	12252479	2040-05-17	U-1374		2025-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-003	8829195	2035-10-29	U-1374	Drug substance	2024-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-003	11407735	2040-05-14		Drug substance	2024-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-003	12252478	2040-05-14		Drug product	2025-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-003	12252479	2040-05-17	U-1374		2025-04-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-001	8829195	2035-10-29	U-1374	Drug substance	2021-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-001	11407735	2040-05-14		Drug substance	2022-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-001	12252478	2040-05-14		Drug product	2025-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-001	12252479	2040-05-17	U-1374		2025-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-002	8829195	2035-10-29	U-1374	Drug substance	2021-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-002	11407735	2040-05-14		Drug substance	2022-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-002	12252478	2040-05-14		Drug product	2025-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-002	12252479	2040-05-17	U-1374		2025-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-003	8829195	2035-10-29	U-1374	Drug substance	2024-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-003	11407735	2040-05-14		Drug substance	2024-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-003	12252478	2040-05-14		Drug product	2025-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-003	12252479	2040-05-17	U-1374		2025-04-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215358-001	8829195	2033-05-13	U-1374	Drug substance	2021-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215358-001	11407735	2040-05-14		Drug substance	2022-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215358-001	12252478	2040-05-14		Drug product	2025-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215358-001	12252479	2040-05-17	U-1374		2025-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215358-002	8829195	2033-05-13	U-1374	Drug substance	2021-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215358-002	11407735	2040-05-14		Drug substance	2022-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215358-002	12252478	2040-05-14		Drug product	2025-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215358-002	12252479	2040-05-17	U-1374		2025-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215358-003	8829195	2033-05-13	U-1374	Drug substance	2024-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215358-003	11407735	2040-05-14		Drug substance	2024-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215358-003	12252478	2040-05-14		Drug product	2025-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215358-003	12252479	2040-05-17	U-1374		2025-04-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215358-001	8829195	2033-05-13	U-1374	Drug substance	2021-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215358-001	11407735	2040-05-14		Drug substance	2022-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215358-002	8829195	2033-05-13	U-1374	Drug substance	2021-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215358-002	11407735	2040-05-14		Drug substance	2022-08-23	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 8 · 294 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	N215358-001	NCE	2026-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-001	I-953	2027-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-001	I-954	2027-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-001	M-318	2028-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-001	ODE-381	2028-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-001	ODE-382	2028-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-001	ODE-499	2031-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-001	ODE-500	2031-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-002	NCE	2026-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-002	I-953	2027-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-002	I-954	2027-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-002	M-318	2028-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-002	ODE-381	2028-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-002	ODE-382	2028-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-002	ODE-499	2031-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-002	ODE-500	2031-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-003	NCE	2026-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-003	M-318	2028-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215358-003	ODE*	2028-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-001	NCE	2026-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-001	I-953	2027-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-001	I-954	2027-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-001	ODE-381	2028-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-001	ODE-382	2028-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-001	ODE-499	2031-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-001	ODE-500	2031-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-002	NCE	2026-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-002	I-953	2027-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-002	I-954	2027-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-002	ODE-381	2028-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-002	ODE-382	2028-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-002	ODE-499	2031-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-002	ODE-500	2031-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-003	NCE	2026-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215358-003	ODE*	2028-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215358-001	NCE	2026-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215358-001	I-953	2027-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215358-001	I-954	2027-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215358-001	ODE-381	2028-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215358-001	ODE-382	2028-10-29	`6a471c1ec25d…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ASCIMINIB HYDROCHLORIDE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
C5U34S9XFV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2584320	Internal RxNorm lookup
2584326	Internal RxNorm lookup
2584328	Internal RxNorm lookup
2584330	Internal RxNorm lookup
2680278	Internal RxNorm lookup
2680280	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
e33001e7-3650-42b1-ae56-cddb5c43aa2b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f63ce078-abc5-4119-957d-2b977297ae12	Product name	1	20220524

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0078-1091-20	SCEMBLIX	60 in 1 BOTTLE	TABLET, FILM COATED	60		12
0078-1091-94	SCEMBLIX	14 in 1 BOTTLE	TABLET, FILM COATED	14		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-1091-20	EA - Each	0078-1091	e68f0fa1-ed76-4fe2-aced-9e28d990bcb6	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0078-1091	SCEMBLIX (ASCIMINIB) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	9	Current NDC, Legacy NDC, 2 package rows	20241101_e33001e7-3650-42b1-ae56-cddb5c43aa2b.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
SCEMBLIX	ASCIMINIB	Novartis Pharmaceuticals Corporation	e33001e7-3650-42b1-ae56-cddb5c43aa2b	2025-11-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215358 application number: NDA215358 ndc (product): 0078-1091

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C5U34S9XFV	ASCIMINIB HYDROCHLORIDE	2119669-71-3	ASCIMINIB HYDROCHLORIDE
L1F3R18W77	ASCIMINIB	1492952-76-7	asciminib

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2680278	asciminib 100 MG Oral Tablet	PSN	e33001e7-3650-42b1-ae56-cddb5c43aa2b	12
2584320	asciminib 20 MG Oral Tablet	PSN	e33001e7-3650-42b1-ae56-cddb5c43aa2b	12
2584328	asciminib 40 MG Oral Tablet	PSN	e33001e7-3650-42b1-ae56-cddb5c43aa2b	12
2680280	SCEMBLIX 100 MG Oral Tablet	PSN	e33001e7-3650-42b1-ae56-cddb5c43aa2b	12
2584326	SCEMBLIX 20 MG Oral Tablet	PSN	e33001e7-3650-42b1-ae56-cddb5c43aa2b	12
2584330	SCEMBLIX 40 MG Oral Tablet	PSN	e33001e7-3650-42b1-ae56-cddb5c43aa2b	12
2680280	asciminib 100 MG Oral Tablet [Scemblix]	SBD	e33001e7-3650-42b1-ae56-cddb5c43aa2b	12
2584326	asciminib 20 MG Oral Tablet [Scemblix]	SBD	e33001e7-3650-42b1-ae56-cddb5c43aa2b	12
2584330	asciminib 40 MG Oral Tablet [Scemblix]	SBD	e33001e7-3650-42b1-ae56-cddb5c43aa2b	12
2680278	asciminib 100 MG Oral Tablet	SCD	e33001e7-3650-42b1-ae56-cddb5c43aa2b	12
2584320	asciminib 20 MG Oral Tablet	SCD	e33001e7-3650-42b1-ae56-cddb5c43aa2b	12
2584328	asciminib 40 MG Oral Tablet	SCD	e33001e7-3650-42b1-ae56-cddb5c43aa2b	12
2680278	asciminib 100 MG (equivalent to asciminib HCl 108.10 MG) Oral Tablet	SY	e33001e7-3650-42b1-ae56-cddb5c43aa2b	12
2584320	asciminib 20 MG (equivalent to asciminib HCl 21.62 MG) Oral Tablet	SY	e33001e7-3650-42b1-ae56-cddb5c43aa2b	12
2584328	asciminib 40 MG (equivalent to asciminib HCl 43.24 MG) Oral Tablet	SY	e33001e7-3650-42b1-ae56-cddb5c43aa2b	12
2680280	Scemblix 100 MG (equivalent to asciminib HCl 108.10 MG) Oral Tablet	SY	e33001e7-3650-42b1-ae56-cddb5c43aa2b	12
2680280	Scemblix 100 MG Oral Tablet	SY	e33001e7-3650-42b1-ae56-cddb5c43aa2b	12
2584326	Scemblix 20 MG (equivalent to asciminib HCl 21.62 MG) Oral Tablet	SY	e33001e7-3650-42b1-ae56-cddb5c43aa2b	12
2584326	Scemblix 20 MG Oral Tablet	SY	e33001e7-3650-42b1-ae56-cddb5c43aa2b	12
2584330	Scemblix 40 MG (equivalent to asciminib HCl 43.24 MG) Oral Tablet	SY	e33001e7-3650-42b1-ae56-cddb5c43aa2b	12
2584330	Scemblix 40 MG Oral Tablet	SY	e33001e7-3650-42b1-ae56-cddb5c43aa2b	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-1091-20	00078109120	60 TABLET, FILM COATED in 1 BOTTLE (0078-1091-20)	2021-10-29	0000-00-00	No	No	Current
0078-1091-94	00078109194	14 TABLET, FILM COATED in 1 BOTTLE (0078-1091-94)	2021-10-29	0000-00-00	Yes	No	Current