Rozlytrek

Product NDC: 50242-091
11-digit product format: 502420091
Labeler code: 50242
Product ID: 50242-091_b93e1fc0-614a-4e49-a91d-a409fb2db9f0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ENTRECTINIB
Dosage form: CAPSULE
Route: ORAL
Labeler: Genentech, Inc.
Application: NDA212725
Marketing category: NDA
Marketing start: 2019-08-15
Substance: ENTRECTINIB
Active strength: 100 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N212725-001	ROZLYTREK	ENTRECTINIB	100MG	CAPSULE / ORAL		RLD	2019-08-15
N212725-002	ROZLYTREK	ENTRECTINIB	200MG	CAPSULE / ORAL		RLD, RS	2019-08-15

Orange Book patents#

Current patent rows page 1 of 1 · 38 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212725-001	8673893	2028-07-08	U-2617		2019-09-13
N212725-001	8673893	2028-07-08	U-2618		2019-09-13
N212725-001	9029356	2028-07-08		Drug substance, Drug product	2019-09-13
N212725-001	9085558	2028-07-08		Drug product	2019-09-13
N212725-001	9255087	2028-07-08	U-2617		2019-09-13
N212725-001	9255087	2028-07-08	U-2618		2019-09-13
N212725-001	9616059	2028-07-08	U-2618		2019-09-13
N212725-001	8299057	2032-03-10		Drug substance, Drug product	2019-09-13
N212725-001	9085565	2033-05-22		Drug substance, Drug product	2019-09-13
N212725-001	9649306	2033-05-22	U-2617		2019-09-13
N212725-001	9649306	2033-05-22	U-2618		2019-09-13
N212725-001	10231965	2035-02-17	U-2617		2019-09-13
N212725-001	10231965	2035-02-17	U-2618		2019-09-13
N212725-001	10561651	2035-02-19	U-2745		2020-03-13
N212725-001	10738037	2037-05-18	U-2946	Drug substance, Drug product	2020-09-09
N212725-001	11091469	2037-05-18	U-2617		2021-09-10
N212725-001	11091469	2037-05-18	U-2618		2021-09-10
N212725-001	10398693	2038-07-18		Drug product	2019-09-13
N212725-001	11253515	2038-07-18		Drug product	2022-03-22
N212725-002	8673893	2028-07-08	U-2617		2019-09-13
N212725-002	8673893	2028-07-08	U-2618		2019-09-13
N212725-002	9029356	2028-07-08		Drug substance, Drug product	2019-09-13
N212725-002	9085558	2028-07-08		Drug product	2019-09-13
N212725-002	9255087	2028-07-08	U-2617		2019-09-13
N212725-002	9255087	2028-07-08	U-2618		2019-09-13
N212725-002	9616059	2028-07-08	U-2618		2019-09-13
N212725-002	8299057	2032-03-10		Drug substance, Drug product	2019-09-13
N212725-002	9085565	2033-05-22		Drug substance, Drug product	2019-09-13
N212725-002	9649306	2033-05-22	U-2617		2019-09-13
N212725-002	9649306	2033-05-22	U-2618		2019-09-13
N212725-002	10231965	2035-02-17	U-2617		2019-09-13
N212725-002	10231965	2035-02-17	U-2618		2019-09-13
N212725-002	10561651	2035-02-19	U-2745		2020-03-13
N212725-002	10738037	2037-05-18	U-2946	Drug substance, Drug product	2020-09-09
N212725-002	11091469	2037-05-18	U-2617		2021-09-10
N212725-002	11091469	2037-05-18	U-2618		2021-09-10
N212725-002	10398693	2038-07-18		Drug product	2019-09-13
N212725-002	11253515	2038-07-18		Drug product	2022-03-22

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 8 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212725-001	ODE-265	2026-08-15
N212725-001	ODE-313	2026-08-15
N212725-001	NPP	2026-10-20
N212725-001	ODE-448	2030-10-20
N212725-002	ODE-265	2026-08-15
N212725-002	ODE-313	2026-08-15
N212725-002	NPP	2026-10-20
N212725-002	ODE-448	2030-10-20

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 · 80 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	N212725-001	ROZLYTREK	100MG	CAPSULE / ORAL	RLD	2019-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-002	ROZLYTREK	200MG	CAPSULE / ORAL	RLD, RS	2019-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212725-001	ROZLYTREK	100MG	CAPSULE / ORAL	RLD	2019-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212725-002	ROZLYTREK	200MG	CAPSULE / ORAL	RLD, RS	2019-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212725-001	ROZLYTREK	100MG	CAPSULE / ORAL	RLD	2019-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212725-002	ROZLYTREK	200MG	CAPSULE / ORAL	RLD, RS	2019-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212725-001	ROZLYTREK	100MG	CAPSULE / ORAL	RLD	2019-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212725-002	ROZLYTREK	200MG	CAPSULE / ORAL	RLD, RS	2019-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212725-001	ROZLYTREK	100MG	CAPSULE / ORAL	RLD	2019-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212725-002	ROZLYTREK	200MG	CAPSULE / ORAL	RLD, RS	2019-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212725-001	ROZLYTREK	100MG	CAPSULE / ORAL	RLD	2019-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212725-002	ROZLYTREK	200MG	CAPSULE / ORAL	RLD, RS	2019-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212725-001	ROZLYTREK	100MG	CAPSULE / ORAL	RLD	2019-08-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212725-002	ROZLYTREK	200MG	CAPSULE / ORAL	RLD, RS	2019-08-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212725-001	ROZLYTREK	100MG	CAPSULE / ORAL	RLD	2019-08-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212725-002	ROZLYTREK	200MG	CAPSULE / ORAL	RLD, RS	2019-08-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212725-001	ROZLYTREK	100MG	CAPSULE / ORAL	RLD	2019-08-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212725-002	ROZLYTREK	200MG	CAPSULE / ORAL	RLD, RS	2019-08-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212725-001	ROZLYTREK	100MG	CAPSULE / ORAL	RLD	2019-08-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212725-002	ROZLYTREK	200MG	CAPSULE / ORAL	RLD, RS	2019-08-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212725-001	ROZLYTREK	100MG	CAPSULE / ORAL	RLD	2019-08-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212725-002	ROZLYTREK	200MG	CAPSULE / ORAL	RLD, RS	2019-08-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212725-001	ROZLYTREK	100MG	CAPSULE / ORAL	RLD	2019-08-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212725-002	ROZLYTREK	200MG	CAPSULE / ORAL	RLD, RS	2019-08-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212725-001	ROZLYTREK	100MG	CAPSULE / ORAL	RLD	2019-08-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212725-002	ROZLYTREK	200MG	CAPSULE / ORAL	RLD, RS	2019-08-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212725-001	ROZLYTREK	100MG	CAPSULE / ORAL	RLD	2019-08-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N212725-002	ROZLYTREK	200MG	CAPSULE / ORAL	RLD, RS	2019-08-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212725-001	ROZLYTREK	100MG	CAPSULE / ORAL	RLD	2019-08-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212725-002	ROZLYTREK	200MG	CAPSULE / ORAL	RLD, RS	2019-08-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212725-001	ROZLYTREK	100MG	CAPSULE / ORAL	RLD	2019-08-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N212725-002	ROZLYTREK	200MG	CAPSULE / ORAL	RLD, RS	2019-08-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212725-001	ROZLYTREK	100MG	CAPSULE / ORAL	RLD	2019-08-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N212725-002	ROZLYTREK	200MG	CAPSULE / ORAL	RLD, RS	2019-08-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N212725-001	ROZLYTREK	100MG	CAPSULE / ORAL	RLD	2019-08-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N212725-002	ROZLYTREK	200MG	CAPSULE / ORAL	RLD, RS	2019-08-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N212725-001	ROZLYTREK	100MG	CAPSULE / ORAL	RLD	2019-08-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N212725-002	ROZLYTREK	200MG	CAPSULE / ORAL	RLD, RS	2019-08-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212725-001	ROZLYTREK	100MG	CAPSULE / ORAL	RLD	2019-08-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N212725-002	ROZLYTREK	200MG	CAPSULE / ORAL	RLD, RS	2019-08-15	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 36 · 1,432 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	N212725-001	8673893	2028-07-08	U-2618		2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-001	8673893	2028-07-08	U-2617		2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-001	9029356	2028-07-08		Drug substance, Drug product	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-001	9085558	2028-07-08		Drug product	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-001	9255087	2028-07-08	U-2618		2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-001	9255087	2028-07-08	U-2617		2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-001	9616059	2028-07-08	U-2618		2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-001	8299057	2032-03-10		Drug substance, Drug product	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-001	9085565	2033-05-22		Drug substance, Drug product	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-001	9649306	2033-05-22	U-2618		2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-001	9649306	2033-05-22	U-2617		2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-001	10231965	2035-02-17	U-2618		2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-001	10231965	2035-02-17	U-2617		2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-001	10561651	2035-02-19	U-2745		2020-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-001	10738037	2037-05-18	U-2946	Drug substance, Drug product	2020-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-001	11091469	2037-05-18	U-2617		2021-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-001	11091469	2037-05-18	U-2618		2021-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-001	10398693	2038-07-18		Drug product	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-001	11253515	2038-07-18		Drug product	2022-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-002	8673893	2028-07-08	U-2618		2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-002	8673893	2028-07-08	U-2617		2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-002	9029356	2028-07-08		Drug substance, Drug product	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-002	9085558	2028-07-08		Drug product	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-002	9255087	2028-07-08	U-2618		2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-002	9255087	2028-07-08	U-2617		2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-002	9616059	2028-07-08	U-2618		2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-002	8299057	2032-03-10		Drug substance, Drug product	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-002	9085565	2033-05-22		Drug substance, Drug product	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-002	9649306	2033-05-22	U-2618		2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-002	9649306	2033-05-22	U-2617		2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-002	10231965	2035-02-17	U-2618		2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-002	10231965	2035-02-17	U-2617		2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-002	10561651	2035-02-19	U-2745		2020-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-002	10738037	2037-05-18	U-2946	Drug substance, Drug product	2020-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-002	11091469	2037-05-18	U-2617		2021-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-002	11091469	2037-05-18	U-2618		2021-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-002	10398693	2038-07-18		Drug product	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-002	11253515	2038-07-18		Drug product	2022-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212725-001	8673893	2028-07-08	U-2618		2019-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212725-001	8673893	2028-07-08	U-2617		2019-09-13	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 8 · 290 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	N212725-001	ODE-265	2026-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-001	ODE-313	2026-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-001	NPP	2026-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-001	ODE-448	2030-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-002	ODE-265	2026-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-002	ODE-313	2026-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-002	NPP	2026-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212725-002	ODE-448	2030-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212725-001	ODE-265	2026-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212725-001	ODE-313	2026-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212725-001	NPP	2026-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212725-001	ODE-448	2030-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212725-002	ODE-265	2026-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212725-002	ODE-313	2026-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212725-002	NPP	2026-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212725-002	ODE-448	2030-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212725-001	ODE-265	2026-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212725-001	ODE-313	2026-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212725-001	NPP	2026-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212725-001	ODE-448	2030-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212725-002	ODE-265	2026-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212725-002	ODE-313	2026-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212725-002	NPP	2026-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212725-002	ODE-448	2030-10-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212725-001	ODE-265	2026-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212725-001	ODE-313	2026-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212725-001	NPP	2026-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212725-001	ODE-448	2030-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212725-002	ODE-265	2026-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212725-002	ODE-313	2026-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212725-002	NPP	2026-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212725-002	ODE-448	2030-10-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212725-001	ODE-265	2026-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212725-001	ODE-313	2026-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212725-001	NPP	2026-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212725-001	ODE-448	2030-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212725-002	ODE-265	2026-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212725-002	ODE-313	2026-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212725-002	NPP	2026-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212725-002	ODE-448	2030-10-20	`b8a1b40f171c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ENTRECTINIB	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L5ORF0AN1I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2197867	Internal RxNorm lookup
2197873	Internal RxNorm lookup
2197875	Internal RxNorm lookup
2197877	Internal RxNorm lookup
2668595	Internal RxNorm lookup
2668599	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
c7c71b0c-2549-4495-86b6-c2807fa54908	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e6575cfe-b3b7-4da4-be93-fa17ff8a6d0a	Product name	2	20250721
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50242-091-30	Rozlytrek	1 in 1 CARTON	CAPSULE	1	18
50242-091-30	Rozlytrek	30 in 1 BOTTLE	CAPSULE	30	18
50242-091-86	Rozlytrek	30 in 1 BOTTLE	CAPSULE	30	18
50242-091-86	Rozlytrek	1 in 1 CARTON	CAPSULE	1	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50242-091-30	EA - Each	50242-091	18a0a217-c9ca-45e0-a4c2-5c5003e8bec4	1	2019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50242-091	ROZLYTREK (ENTRECTINIB) CAPSULE ROZLYTREK (ENTRECTINIB) PELLET [GENENTECH, INC.]	15	Current NDC, Legacy NDC, 4 package rows	20241123_c7c71b0c-2549-4495-86b6-c2807fa54908.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
Rozlytrek	ENTRECTINIB	Genentech, Inc.	c7c71b0c-2549-4495-86b6-c2807fa54908	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212725 application number: NDA212725 ndc (product): 50242-091

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L5ORF0AN1I	ENTRECTINIB	1108743-60-7	ENTRECTINIB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2197867	entrectinib 100 MG Oral Capsule	PSN	c7c71b0c-2549-4495-86b6-c2807fa54908	18
2197875	entrectinib 200 MG Oral Capsule	PSN	c7c71b0c-2549-4495-86b6-c2807fa54908	18
2668595	entrectinib 50 MG Oral Pellet	PSN	c7c71b0c-2549-4495-86b6-c2807fa54908	18
2197873	ROZLYTREK 100 MG Oral Capsule	PSN	c7c71b0c-2549-4495-86b6-c2807fa54908	18
2197877	ROZLYTREK 200 MG Oral Capsule	PSN	c7c71b0c-2549-4495-86b6-c2807fa54908	18
2668599	ROZLYTREK 50 MG Oral Pellet	PSN	c7c71b0c-2549-4495-86b6-c2807fa54908	18
2197873	entrectinib 100 MG Oral Capsule [Rozlytrek]	SBD	c7c71b0c-2549-4495-86b6-c2807fa54908	18
2197877	entrectinib 200 MG Oral Capsule [Rozlytrek]	SBD	c7c71b0c-2549-4495-86b6-c2807fa54908	18
2668599	entrectinib 50 MG Oral Pellet [Rozlytrek]	SBD	c7c71b0c-2549-4495-86b6-c2807fa54908	18
2197867	entrectinib 100 MG Oral Capsule	SCD	c7c71b0c-2549-4495-86b6-c2807fa54908	18
2197875	entrectinib 200 MG Oral Capsule	SCD	c7c71b0c-2549-4495-86b6-c2807fa54908	18
2668595	entrectinib 50 MG Oral Pellet	SCD	c7c71b0c-2549-4495-86b6-c2807fa54908	18
2197873	Rozlytrek 100 MG Oral Capsule	SY	c7c71b0c-2549-4495-86b6-c2807fa54908	18
2197877	Rozlytrek 200 MG Oral Capsule	SY	c7c71b0c-2549-4495-86b6-c2807fa54908	18
2668599	Rozlytrek 50 MG Oral Pellet	SY	c7c71b0c-2549-4495-86b6-c2807fa54908	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50242-091-30	50242009130	1 BOTTLE in 1 CARTON (50242-091-30) / 30 CAPSULE in 1 BOTTLE	1 bottle	2019-08-15	0000-00-00	No	No	Current
50242-091-86	50242009186	1 BOTTLE in 1 CARTON (50242-091-86) / 30 CAPSULE in 1 BOTTLE	1 bottle	2019-08-15	0000-00-00	Yes	No	Current