Home NDC 50242-210 Gavreto
Product NDC 50242-210
11-digit product format 502420210
Labeler code 50242
Product ID 50242-210_202f12fc-4f57-4e69-bf7b-73d7c1d1ed0c
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 2026-09-30
Substance PRALSETINIB
Active strength 100 mg/1
Pharmacologic classes Kinase Inhibitor [EPC], Rearranged during Transfection (RET) Inhibitors [MoA]
NDC exclude flag No
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 N213721-001 GAVRETO PRALSETINIB 100MG CAPSULE / ORAL RLD, RS 2020-09-04
Orange Book patents# Current patent rows page 1 of 1 · 7 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 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
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 Product TE source text RLD / RS Approval date Source SHA-256 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 4 · 150 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 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…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213721-001 11872192 2039-04-03 U-2952 2024-02-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213721-001 11963958 2039-04-03 U-2828 2024-05-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213721-001 10030005 2036-11-01 U-2952 Drug substance, Drug product 2020-10-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213721-001 10030005 2036-11-01 U-3002 Drug substance, Drug product 2020-10-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213721-001 11273160 2039-04-03 U-2952 2022-03-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213721-001 11872192 2039-04-03 U-2952 2024-02-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213721-001 11963958 2039-04-03 U-2828 2024-05-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213721-001 10030005 2036-11-01 U-2952 Drug substance, Drug product 2020-10-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213721-001 10030005 2036-11-01 U-3002 Drug substance, Drug product 2020-10-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213721-001 11273160 2039-04-03 U-2952 2022-03-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213721-001 11872192 2039-04-03 U-2952 2024-02-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213721-001 11963958 2039-04-03 U-2828 2024-05-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213721-001 10030005 2036-11-01 U-2952 Drug substance, Drug product 2020-10-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213721-001 10030005 2036-11-01 U-3002 Drug substance, Drug product 2020-10-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213721-001 11273160 2039-04-03 U-2952 2022-03-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213721-001 11872192 2039-04-03 U-2952 2024-02-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213721-001 11963958 2039-04-03 U-2828 2024-05-13 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 136 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Gavreto Active Ingredients# Ingredient, Strength table Ingredient Strength PRALSETINIB 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1WPE73O1WV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2394941 Internal RxNorm lookup 2394947 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# 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 Current NDC, 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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50242-210-12 50242021012 1 BOTTLE in 1 CARTON (50242-210-12) > 120 CAPSULE in 1 BOTTLE 1 bottle 2021-07-01 0000-00-00 No No Current 50242-210-60 50242021060 1 BOTTLE in 1 CARTON (50242-210-60) / 60 CAPSULE in 1 BOTTLE 1 bottle 2021-07-01 2026-09-30 No No Current 50242-210-83 50242021083 1 BOTTLE in 1 CARTON (50242-210-83) / 60 CAPSULE in 1 BOTTLE 1 bottle 2021-07-01 2026-09-30 Yes No Current 50242-210-86 50242021086 1 BOTTLE in 1 CARTON (50242-210-86) > 120 CAPSULE in 1 BOTTLE 1 bottle 2020-09-15 0000-00-00 Yes No Current 50242-210-90 50242021090 1 BOTTLE in 1 CARTON (50242-210-90) / 90 CAPSULE in 1 BOTTLE 1 bottle 2021-07-01 2026-09-30 No No Current