VITRAKVI

Product NDC: 50419-392
11-digit product format: 504190392
Labeler code: 50419
Product ID: 50419-392_0e3ba6e7-af8d-4840-9409-a537a09e1263
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LAROTRECTINIB
Dosage form: SOLUTION, CONCENTRATE
Route: OROPHARYNGEAL
Labeler: Bayer HealthCare Pharmaceuticals Inc.
Application: NDA211710
Marketing category: NDA
Marketing start: 2019-07-26
Substance: LAROTRECTINIB
Active strength: 20 mg/mL
Pharmacologic classes: Kinase Inhibitor [EPC], Tropomyosin Receptor Kinases Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N211710-001	VITRAKVI	LAROTRECTINIB SULFATE	EQ 20MG BASE/ML	SOLUTION / ORAL		RLD, RS	2018-11-26

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211710-001	10005783	2029-10-21	U-2472		2018-12-20
N211710-001	10047097	2029-10-21	U-2474		2018-12-20
N211710-001	10774085	2029-10-21	U-2470		2020-10-14
N211710-001	8865698	2029-10-21	U-2469		2018-12-20
N211710-001	9127013	2029-10-21		Drug substance, Drug product	2018-12-20
N211710-001	9447104	2029-10-21	U-2470		2018-12-20
N211710-001	9676783	2029-10-21	U-2469		2018-12-20
N211710-001	8513263	2029-12-23		Drug substance, Drug product	2018-12-20
N211710-001	10172861	2035-11-16		Drug substance	2019-06-13
N211710-001	9782414	2035-11-16	U-2471		2018-12-20
N211710-001	10799505	2036-08-15		Drug substance	2021-04-01
N211710-001	10045991	2037-04-04	U-2473		2018-12-20
N211710-001	10137127	2037-04-04		Drug product	2018-12-20
N211710-001	10668072	2037-04-04		Drug product	2020-09-17
N211710-001	11191766	2037-04-04	U-2471		2023-03-10
N211710-001	11484535	2037-04-04	U-2470		2023-03-10
N211710-001	11337967	2037-05-16	U-4123		2025-02-19
N211710-001	11974998	2037-05-16	U-4124		2025-02-19

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	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211710-001	VITRAKVI	EQ 20MG BASE/ML	SOLUTION / ORAL	RLD, RS	2018-11-26	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 16 · 615 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	N211710-001	10005783	2029-10-21	U-2472		2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211710-001	10047097	2029-10-21	U-2474		2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211710-001	10774085	2029-10-21	U-2470		2020-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211710-001	8865698	2029-10-21	U-2469		2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211710-001	9127013	2029-10-21		Drug substance, Drug product	2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211710-001	9447104	2029-10-21	U-2470		2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211710-001	9676783	2029-10-21	U-2469		2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211710-001	8513263	2029-12-23		Drug substance, Drug product	2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211710-001	10172861	2035-11-16		Drug substance	2019-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211710-001	9782414	2035-11-16	U-2471		2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211710-001	10799505	2036-08-15		Drug substance	2021-04-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211710-001	10045991	2037-04-04	U-2473		2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211710-001	10137127	2037-04-04		Drug product	2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211710-001	10668072	2037-04-04		Drug product	2020-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211710-001	11191766	2037-04-04	U-2471		2023-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211710-001	11484535	2037-04-04	U-2470		2023-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211710-001	11337967	2037-05-16	U-4123		2025-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211710-001	11974998	2037-05-16	U-4124		2025-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211710-001	10005783	2029-10-21	U-2472		2018-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211710-001	10047097	2029-10-21	U-2474		2018-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211710-001	10774085	2029-10-21	U-2470		2020-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211710-001	8865698	2029-10-21	U-2469		2018-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211710-001	9127013	2029-10-21		Drug substance, Drug product	2018-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211710-001	9447104	2029-10-21	U-2470		2018-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211710-001	9676783	2029-10-21	U-2469		2018-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211710-001	8513263	2029-12-23		Drug substance, Drug product	2018-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211710-001	10172861	2035-11-16		Drug substance	2019-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211710-001	9782414	2035-11-16	U-2471		2018-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211710-001	10799505	2036-08-15		Drug substance	2021-04-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211710-001	10045991	2037-04-04	U-2473		2018-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211710-001	10137127	2037-04-04		Drug product	2018-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211710-001	10668072	2037-04-04		Drug product	2020-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211710-001	11191766	2037-04-04	U-2471		2023-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211710-001	11484535	2037-04-04	U-2470		2023-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211710-001	11337967	2037-05-16	U-4123		2025-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211710-001	11974998	2037-05-16	U-4124		2025-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211710-001	10005783	2029-10-21	U-2472		2018-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211710-001	10047097	2029-10-21	U-2474		2018-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211710-001	10774085	2029-10-21	U-2470		2020-10-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211710-001	8865698	2029-10-21	U-2469		2018-12-20	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 141 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211710-001	ODE-215	2025-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211710-001	ODE-220	2025-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211710-001	ODE-221	2025-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211710-001	ODE-215	2025-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211710-001	ODE-220	2025-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211710-001	ODE-221	2025-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211710-001	ODE-215	2025-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211710-001	ODE-220	2025-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211710-001	ODE-221	2025-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211710-001	ODE-215	2025-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211710-001	ODE-220	2025-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211710-001	ODE-221	2025-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211710-001	ODE-215	2025-11-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211710-001	ODE-220	2025-11-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211710-001	ODE-221	2025-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211710-001	ODE-215	2025-11-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211710-001	ODE-220	2025-11-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211710-001	ODE-221	2025-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211710-001	ODE-215	2025-11-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211710-001	ODE-220	2025-11-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211710-001	ODE-221	2025-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211710-001	ODE-215	2025-11-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211710-001	ODE-220	2025-11-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211710-001	ODE-221	2025-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211710-001	ODE-215	2025-11-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211710-001	ODE-220	2025-11-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211710-001	ODE-221	2025-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211710-001	ODE-215	2025-11-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211710-001	ODE-220	2025-11-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211710-001	ODE-221	2025-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211710-001	ODE-215	2025-11-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211710-001	ODE-220	2025-11-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211710-001	ODE-221	2025-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211710-001	ODE-215	2025-11-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211710-001	ODE-220	2025-11-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211710-001	ODE-221	2025-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211710-001	ODE-215	2025-11-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211710-001	ODE-220	2025-11-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211710-001	ODE-221	2025-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211710-001	NCE	2023-11-26	`5c6f7cd8ea54…`

Additional Listing Data#

Finished product: Yes
Brand name base: VITRAKVI
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LAROTRECTINIB	20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
PF9462I9HX	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2105633	Internal RxNorm lookup
2105645	Internal RxNorm lookup
2105649	Internal RxNorm lookup
2105653	Internal RxNorm lookup
2105655	Internal RxNorm lookup
2105657	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
0c8ca614-58b2-4aa4-83d3-0387a8f782fd	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
0fc8d6a0-e17e-438b-8b82-328781db0b4c	Product name	2	20190320
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50419-392-01	2024-01-30	C162847	48780-1	1030e365-05f3-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use VITRAKVI safely and effectively. See full prescribing information for VITRAKVI. VITRAKVI ® (larotrectinib) capsules, for oral use VITRAKVI ® (larotrectinib) oral solution Initial U.S. Approval: 2018
50419-392-01	2024-01-30	C162847	48780-1	1030e365-05f3-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use VITRAKVI safely and effectively. See full prescribing information for VITRAKVI. VITRAKVI ® (larotrectinib) capsules, for oral use VITRAKVI ® (larotrectinib) oral solution Initial U.S. Approval: 2018
50419-392-01	2024-01-30	C162847	48780-1	1030e365-05f3-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use VITRAKVI safely and effectively. See full prescribing information for VITRAKVI. VITRAKVI ® (larotrectinib) capsules, for oral use VITRAKVI ® (larotrectinib) oral solution Initial U.S. Approval: 2018

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50419-392-01	VITRAKVI	100 mL in 1 BOTTLE	SOLUTION, CONCENTRATE	100		21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50419-392-01	ML - Milliliter	50419-392	0163b18b-b83b-4d8e-9087-dbe4b7e58183	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50419-392	VITRAKVI (LAROTRECTINIB) CAPSULE VITRAKVI (LAROTRECTINIB) SOLUTION, CONCENTRATE [BAYER HEALTHCARE PHARMACEUTICALS INC.]	11	Current NDC, Legacy NDC, 1 package rows	20250506_0c8ca614-58b2-4aa4-83d3-0387a8f782fd.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VITRAKVI	LAROTRECTINIB	Bayer HealthCare Pharmaceuticals Inc.	0c8ca614-58b2-4aa4-83d3-0387a8f782fd	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211710 application number: NDA211710 ndc (product): 50419-392
VITRAKVI	LAROTRECTINIB	Loxo Oncology, Inc.	9525f887-a055-4e33-8e92-898d42828cd1	2018-12-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211710 application number: NDA211710

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
PF9462I9HX	LAROTRECTINIB	1223403-58-4	LAROTRECTINIB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2105633	larotrectinib 100 MG Oral Capsule	PSN	0c8ca614-58b2-4aa4-83d3-0387a8f782fd	21
2105649	larotrectinib 20 MG in 1 mL Oral Solution	PSN	0c8ca614-58b2-4aa4-83d3-0387a8f782fd	21
2105655	larotrectinib 25 MG Oral Capsule	PSN	0c8ca614-58b2-4aa4-83d3-0387a8f782fd	21
2105645	VITRAKVI 100 MG Oral Capsule	PSN	0c8ca614-58b2-4aa4-83d3-0387a8f782fd	21
2105653	VITRAKVI 20 MG in 1 mL Oral Solution	PSN	0c8ca614-58b2-4aa4-83d3-0387a8f782fd	21
2105657	VITRAKVI 25 MG Oral Capsule	PSN	0c8ca614-58b2-4aa4-83d3-0387a8f782fd	21
2105645	larotrectinib 100 MG Oral Capsule [Vitrakvi]	SBD	0c8ca614-58b2-4aa4-83d3-0387a8f782fd	21
2105653	larotrectinib 20 MG/ML Oral Solution [Vitrakvi]	SBD	0c8ca614-58b2-4aa4-83d3-0387a8f782fd	21
2105657	larotrectinib 25 MG Oral Capsule [Vitrakvi]	SBD	0c8ca614-58b2-4aa4-83d3-0387a8f782fd	21
2105633	larotrectinib 100 MG Oral Capsule	SCD	0c8ca614-58b2-4aa4-83d3-0387a8f782fd	21
2105649	larotrectinib 20 MG/ML Oral Solution	SCD	0c8ca614-58b2-4aa4-83d3-0387a8f782fd	21
2105655	larotrectinib 25 MG Oral Capsule	SCD	0c8ca614-58b2-4aa4-83d3-0387a8f782fd	21
2105633	larotrectinib 100 MG (as 123 MG larotrectinib sulfate) oral capsule	SY	0c8ca614-58b2-4aa4-83d3-0387a8f782fd	21
2105649	larotrectinib 20 MG (as 24.6 MG larotrectinib sulfate) per 1 ML Oral Solution	SY	0c8ca614-58b2-4aa4-83d3-0387a8f782fd	21
2105649	larotrectinib 20 MG per 1 ML Oral Solution	SY	0c8ca614-58b2-4aa4-83d3-0387a8f782fd	21
2105655	larotrectinib 25 MG (as 30.7 MG larotrectinib sulfate) Oral Capsule	SY	0c8ca614-58b2-4aa4-83d3-0387a8f782fd	21
2105645	Vitrakvi 100 MG (as 123 MG larotrectinib sulfate) Oral Capsule	SY	0c8ca614-58b2-4aa4-83d3-0387a8f782fd	21
2105645	Vitrakvi 100 MG Oral Capsule	SY	0c8ca614-58b2-4aa4-83d3-0387a8f782fd	21
2105653	Vitrakvi 20 MG (as 24.6 MG larotrectinib sulfate) per 1 mL Oral Solution	SY	0c8ca614-58b2-4aa4-83d3-0387a8f782fd	21
2105653	Vitrakvi 20 MG per 1 mL Oral Solution	SY	0c8ca614-58b2-4aa4-83d3-0387a8f782fd	21
2105653	Vitrakvi 20 MG/ML Oral Solution	SY	0c8ca614-58b2-4aa4-83d3-0387a8f782fd	21
2105657	Vitrakvi 25 MG (as 30.7 MG larotrectinib sulfate) Oral Capsule	SY	0c8ca614-58b2-4aa4-83d3-0387a8f782fd	21
2105657	Vitrakvi 25 MG Oral Capsule	SY	0c8ca614-58b2-4aa4-83d3-0387a8f782fd	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50419-392-01	50419039201	100 mL in 1 BOTTLE (50419-392-01)	100 ml	2019-07-26	0000-00-00	No	No	Current