Gavreto

Product NDC: 50242-210
Requested package NDC: 50242-210-60
11-digit product format: 502420210
Labeler code: 50242
Product ID: 50242-210_c06062fd-6db9-4140-933e-6758cb2ae714
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pralsetinib
Dosage form: CAPSULE
Route: ORAL
Labeler: Genentech, Inc.
Application: NDA213721
Marketing category: NDA
Marketing start: 2021-07-01
Marketing end: 0000-00-00
Substance: PRALSETINIB
Active strength: 100 mg/1
Pharmacologic classes: Kinase Inhibitor [EPC], Rearranged during Transfection (RET) Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50242-210	50242-210-60	D	Discontinued by firm		2026-10-05

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
N213721-001	GAVRETO	PRALSETINIB	100MG	CAPSULE / ORAL		RLD, RS	2020-09-04

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213721-001	10030005	2036-11-01	U-2952	Drug substance, Drug product	2020-10-01
N213721-001	10030005	2036-11-01	U-3002	Drug substance, Drug product	2020-10-01
N213721-001	12655128	2036-11-01		Drug substance, Drug product	2026-07-15
N213721-001	11273160	2039-04-03	U-2952		2022-03-22
N213721-001	11872192	2039-04-03	U-2952		2024-02-06
N213721-001	11963958	2039-04-03	U-2828		2024-05-13
N213721-001	12539303	2039-04-03	U-2828		2026-03-04
N213721-001	12448366	2042-07-07		Drug substance	2026-02-17
N213721-001	12692251	2043-04-19		Drug product	2026-08-27

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N213721-001	ODE-318	2027-09-04
N213721-001	ODE-340	2027-12-01
N213721-001	ODE-341	2027-12-01

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.

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	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213721-001	GAVRETO	100MG	CAPSULE / ORAL	RLD, RS	2020-09-04	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 167 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	N213721-001	10030005	2036-11-01	U-2952	Drug substance, Drug product	2020-10-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213721-001	10030005	2036-11-01	U-3002	Drug substance, Drug product	2020-10-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213721-001	12655128	2036-11-01		Drug substance, Drug product	2026-07-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213721-001	11273160	2039-04-03	U-2952		2022-03-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213721-001	11872192	2039-04-03	U-2952		2024-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213721-001	11963958	2039-04-03	U-2828		2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213721-001	12539303	2039-04-03	U-2828		2026-03-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213721-001	12448366	2042-07-07		Drug substance	2026-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213721-001	12692251	2043-04-19		Drug product	2026-08-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213721-001	10030005	2036-11-01	U-2952	Drug substance, Drug product	2020-10-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213721-001	10030005	2036-11-01	U-3002	Drug substance, Drug product	2020-10-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213721-001	12655128	2036-11-01		Drug substance, Drug product	2026-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213721-001	11273160	2039-04-03	U-2952		2022-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213721-001	11872192	2039-04-03	U-2952		2024-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213721-001	11963958	2039-04-03	U-2828		2024-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213721-001	12539303	2039-04-03	U-2828		2026-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213721-001	12448366	2042-07-07		Drug substance	2026-02-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213721-001	10030005	2036-11-01	U-2952	Drug substance, Drug product	2020-10-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213721-001	10030005	2036-11-01	U-3002	Drug substance, Drug product	2020-10-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213721-001	11273160	2039-04-03	U-2952		2022-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213721-001	11872192	2039-04-03	U-2952		2024-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213721-001	11963958	2039-04-03	U-2828		2024-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213721-001	10030005	2036-11-01	U-2952	Drug substance, Drug product	2020-10-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213721-001	10030005	2036-11-01	U-3002	Drug substance, Drug product	2020-10-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213721-001	11273160	2039-04-03	U-2952		2022-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213721-001	11872192	2039-04-03	U-2952		2024-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213721-001	11963958	2039-04-03	U-2828		2024-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213721-001	10030005	2036-11-01	U-2952	Drug substance, Drug product	2020-10-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213721-001	10030005	2036-11-01	U-3002	Drug substance, Drug product	2020-10-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213721-001	11273160	2039-04-03	U-2952		2022-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213721-001	11872192	2039-04-03	U-2952		2024-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213721-001	11963958	2039-04-03	U-2828		2024-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213721-001	10030005	2036-11-01	U-2952	Drug substance, Drug product	2020-10-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213721-001	10030005	2036-11-01	U-3002	Drug substance, Drug product	2020-10-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213721-001	11273160	2039-04-03	U-2952		2022-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213721-001	11872192	2039-04-03	U-2952		2024-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213721-001	11963958	2039-04-03	U-2828		2024-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213721-001	10030005	2036-11-01	U-2952	Drug substance, Drug product	2020-10-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213721-001	10030005	2036-11-01	U-3002	Drug substance, Drug product	2020-10-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213721-001	11273160	2039-04-03	U-2952		2022-03-22	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 142 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	N213721-001	ODE-318	2027-09-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213721-001	ODE-340	2027-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213721-001	ODE-341	2027-12-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213721-001	ODE-318	2027-09-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213721-001	ODE-340	2027-12-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213721-001	ODE-341	2027-12-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213721-001	ODE-318	2027-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213721-001	ODE-340	2027-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213721-001	ODE-341	2027-12-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213721-001	NCE	2025-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213721-001	ODE-318	2027-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213721-001	ODE-340	2027-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213721-001	ODE-341	2027-12-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213721-001	NCE	2025-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213721-001	ODE-318	2027-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213721-001	ODE-340	2027-12-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213721-001	ODE-341	2027-12-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213721-001	NCE	2025-09-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213721-001	ODE-318	2027-09-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213721-001	ODE-340	2027-12-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213721-001	ODE-341	2027-12-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213721-001	NCE	2025-09-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213721-001	ODE-318	2027-09-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213721-001	ODE-340	2027-12-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213721-001	ODE-341	2027-12-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213721-001	NCE	2025-09-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213721-001	ODE-318	2027-09-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213721-001	ODE-340	2027-12-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213721-001	ODE-341	2027-12-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213721-001	NCE	2025-09-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213721-001	ODE-318	2027-09-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213721-001	ODE-340	2027-12-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213721-001	ODE-341	2027-12-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213721-001	NCE	2025-09-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213721-001	ODE-318	2027-09-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213721-001	ODE-340	2027-12-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213721-001	ODE-341	2027-12-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213721-001	NCE	2025-09-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213721-001	ODE-318	2027-09-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213721-001	ODE-340	2027-12-01	`d8e5a09893c0…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
b01d7c5e-8a19-4838-b13a-e7dff83e1be3	Product name	1	20210511
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50242-210-12	Gavreto	120 in 1 BOTTLE	CAPSULE	120	18
50242-210-12	Gavreto	1 in 1 CARTON	CAPSULE	1	18
50242-210-60	Gavreto	60 in 1 BOTTLE	CAPSULE	60	18
50242-210-60	Gavreto	1 in 1 CARTON	CAPSULE	1	18
50242-210-83	Gavreto	1 in 1 CARTON	CAPSULE	1	18
50242-210-83	Gavreto	60 in 1 BOTTLE	CAPSULE	60	18
50242-210-90	Gavreto	90 in 1 BOTTLE	CAPSULE	90	18
50242-210-90	Gavreto	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
50242-210-60	EA - Each	50242-210	a842d32a-216b-42d1-bd66-a785f2df9fa6	1	2021-06-02
50242-210-90	EA - Each	50242-210	543d1917-f2b6-451d-b199-d966737f3292	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50242-210	GAVRETO (PRALSETINIB) CAPSULE [GENENTECH, INC.]	16	Legacy NDC, 8 package rows	20241121_59984249-e3ff-4f97-8d7a-c1a905d604a8.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
Gavreto	PRALSETINIB	Rigel Pharmaceuticals, Inc.	16edd46e-28b8-f06d-e063-6394a90ae31b	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 213721 application number: NDA213721
Gavreto	PRALSETINIB	Genentech, Inc.	59984249-e3ff-4f97-8d7a-c1a905d604a8	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213721 application number: NDA213721 ndc (package): 50242-210-60 ndc (product): 50242-210 ndc11 (package): 50242021060

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1WPE73O1WV	PRALSETINIB	2097132-94-8	PRALSETINIB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2394947	GAVRETO 100 MG Oral Capsule	PSN	59984249-e3ff-4f97-8d7a-c1a905d604a8	18
2394941	pralsetinib 100 MG Oral Capsule	PSN	59984249-e3ff-4f97-8d7a-c1a905d604a8	18
2394947	pralsetinib 100 MG Oral Capsule [Gavreto]	SBD	59984249-e3ff-4f97-8d7a-c1a905d604a8	18
2394941	pralsetinib 100 MG Oral Capsule	SCD	59984249-e3ff-4f97-8d7a-c1a905d604a8	18
2394947	Gavreto 100 MG Oral Capsule	SY	59984249-e3ff-4f97-8d7a-c1a905d604a8	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50242-210-60	50242021060	1 BOTTLE in 1 CARTON (50242-210-60) > 60 CAPSULE in 1 BOTTLE	1 bottle	2021-07-01	0000-00-00	No	No	Current