Home NDC 72064-210-12 GAVRETO
Product NDC 72064-210
Requested package NDC 72064-210-12
11-digit product format 720640210
Labeler code 72064
Product ID 72064-210_934fd583-8122-42ed-afc8-733b6006cc3e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pralsetinib
Dosage form CAPSULE
Route ORAL
Labeler Blueprint Medicines Corporation
Application NDA213721
Marketing category NDA
Marketing start 2020-09-04
Marketing end 2022-04-30
Substance PRALSETINIB
Active strength 100 mg/1
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72064-210-12 72064021012 120 CAPSULE in 1 BOTTLE, PLASTIC (72064-210-12) 120 capsule 2020-09-04 2022-04-30 No No Current