Home NDC 72064-120 Ayvakit
Product NDC 72064-120
11-digit product format 720640120
Labeler code 72064
Product ID 72064-120_5cf92ebf-46ff-4b14-becc-848ef1a79282
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name avapritinib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Blueprint Medicines Corporation
Application NDA212608
Marketing category NDA
Marketing start 2020-01-09
Substance AVAPRITINIB
Active strength 200 mg/1
Pharmacologic classes Bile Salt Export Pump Inhibitors [MoA], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Kinase Inhibitor [EPC], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 2 K Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Tyrosine Kinase Inhibitors [MoA]
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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N212608-001 AYVAKIT AVAPRITINIB 100MG TABLET / ORAL RLD 2020-01-09 N212608-002 AYVAKIT AVAPRITINIB 200MG TABLET / ORAL RLD 2020-01-09 N212608-003 AYVAKIT AVAPRITINIB 300MG TABLET / ORAL RLD, RS 2020-01-09 N212608-004 AYVAKIT AVAPRITINIB 25MG TABLET / ORAL RLD 2021-06-16 N212608-005 AYVAKIT AVAPRITINIB 50MG TABLET / ORAL RLD 2021-06-16
Orange Book patents# Current patent rows page 1 of 1 · 39 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212608-001 9200002 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 N212608-001 9200002 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 N212608-001 9944651 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 N212608-001 9944651 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 N212608-001 9994575 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 N212608-001 9994575 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 N212608-001 11964980 2040-04-10 Drug substance, Drug product 2024-04-23 N212608-001 11999744 2040-04-10 U-3168 2024-06-05 N212608-001 12060354 2042-03-08 U-2726 2024-08-14 N212608-002 9200002 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 N212608-002 9200002 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 N212608-002 9944651 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 N212608-002 9944651 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 N212608-002 9994575 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 N212608-002 9994575 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 N212608-002 11964980 2040-04-10 Drug substance, Drug product 2024-04-23 N212608-002 11999744 2040-04-10 U-3168 2024-06-05 N212608-002 12060354 2042-03-08 U-2726 2024-08-14 N212608-003 9200002 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 N212608-003 9944651 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 N212608-003 9994575 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 N212608-003 11964980 2040-04-10 Drug substance, Drug product 2024-04-23 N212608-003 12060354 2042-03-08 U-2726 2024-08-14 N212608-004 11827642 2034-10-15 U-3506 Drug substance, Drug product 2023-12-21 N212608-004 9200002 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 N212608-004 9200002 2034-10-15 U-3506 Drug substance, Drug product 2021-07-13 N212608-004 9944651 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 N212608-004 9944651 2034-10-15 U-3506 Drug substance, Drug product 2021-07-13 N212608-004 9994575 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 N212608-004 9994575 2034-10-15 U-3506 Drug substance, Drug product 2021-07-13 N212608-004 11964980 2040-04-10 Drug substance, Drug product 2024-04-23 N212608-004 11999744 2040-04-10 U-3168 2024-06-05 N212608-004 11999744 2040-04-10 U-3506 2024-06-05 N212608-004 12252494 2040-04-10 U-3506 2025-04-16 N212608-005 9200002 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 N212608-005 9944651 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 N212608-005 9994575 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 N212608-005 11964980 2040-04-10 Drug substance, Drug product 2024-04-23 N212608-005 11999744 2040-04-10 U-3168 2024-06-05
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 16 matching rows.
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 5 · 177 observed 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 N212608-001 AYVAKIT 100MG TABLET / ORAL RLD 2020-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-002 AYVAKIT 200MG TABLET / ORAL RLD 2020-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-003 AYVAKIT 300MG TABLET / ORAL RLD, RS 2020-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-004 AYVAKIT 25MG TABLET / ORAL RLD 2021-06-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-005 AYVAKIT 50MG TABLET / ORAL RLD 2021-06-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212608-001 AYVAKIT 100MG TABLET / ORAL RLD 2020-01-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212608-002 AYVAKIT 200MG TABLET / ORAL RLD 2020-01-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212608-003 AYVAKIT 300MG TABLET / ORAL RLD, RS 2020-01-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212608-004 AYVAKIT 25MG TABLET / ORAL RLD 2021-06-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212608-005 AYVAKIT 50MG TABLET / ORAL RLD 2021-06-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212608-001 AYVAKIT 100MG TABLET / ORAL RLD 2020-01-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212608-002 AYVAKIT 200MG TABLET / ORAL RLD 2020-01-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212608-003 AYVAKIT 300MG TABLET / ORAL RLD, RS 2020-01-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212608-004 AYVAKIT 25MG TABLET / ORAL RLD 2021-06-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212608-005 AYVAKIT 50MG TABLET / ORAL RLD 2021-06-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212608-001 AYVAKIT 100MG TABLET / ORAL RLD 2020-01-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212608-002 AYVAKIT 200MG TABLET / ORAL RLD 2020-01-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212608-003 AYVAKIT 300MG TABLET / ORAL RLD, RS 2020-01-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212608-004 AYVAKIT 25MG TABLET / ORAL RLD 2021-06-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212608-005 AYVAKIT 50MG TABLET / ORAL RLD 2021-06-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212608-001 AYVAKIT 100MG TABLET / ORAL RLD 2020-01-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212608-002 AYVAKIT 200MG TABLET / ORAL RLD 2020-01-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212608-003 AYVAKIT 300MG TABLET / ORAL RLD, RS 2020-01-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212608-004 AYVAKIT 25MG TABLET / ORAL RLD 2021-06-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212608-005 AYVAKIT 50MG TABLET / ORAL RLD 2021-06-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212608-001 AYVAKIT 100MG TABLET / ORAL RLD 2020-01-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212608-002 AYVAKIT 200MG TABLET / ORAL RLD 2020-01-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212608-003 AYVAKIT 300MG TABLET / ORAL RLD, RS 2020-01-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212608-004 AYVAKIT 25MG TABLET / ORAL RLD 2021-06-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212608-005 AYVAKIT 50MG TABLET / ORAL RLD 2021-06-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212608-001 AYVAKIT 100MG TABLET / ORAL RLD 2020-01-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212608-002 AYVAKIT 200MG TABLET / ORAL RLD 2020-01-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212608-003 AYVAKIT 300MG TABLET / ORAL RLD, RS 2020-01-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212608-004 AYVAKIT 25MG TABLET / ORAL RLD 2021-06-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212608-005 AYVAKIT 50MG TABLET / ORAL RLD 2021-06-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212608-001 AYVAKIT 100MG TABLET / ORAL RLD 2020-01-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212608-002 AYVAKIT 200MG TABLET / ORAL RLD 2020-01-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212608-003 AYVAKIT 300MG TABLET / ORAL RLD, RS 2020-01-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212608-004 AYVAKIT 25MG TABLET / ORAL RLD 2021-06-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212608-005 AYVAKIT 50MG TABLET / ORAL RLD 2021-06-16 5bbf6a4d5a75…
Observed Orange Book patent history# Patent history page 1 of 25 · 991 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 N212608-001 9200002 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-001 9200002 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-001 9944651 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-001 9944651 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-001 9994575 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-001 9994575 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-001 11964980 2040-04-10 Drug substance, Drug product 2024-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-001 11999744 2040-04-10 U-3168 2024-06-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-001 12060354 2042-03-08 U-2726 2024-08-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-002 9200002 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-002 9200002 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-002 9944651 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-002 9944651 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-002 9994575 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-002 9994575 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-002 11964980 2040-04-10 Drug substance, Drug product 2024-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-002 11999744 2040-04-10 U-3168 2024-06-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-002 12060354 2042-03-08 U-2726 2024-08-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-003 9200002 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-003 9944651 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-003 9994575 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-003 11964980 2040-04-10 Drug substance, Drug product 2024-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-003 12060354 2042-03-08 U-2726 2024-08-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-004 11827642 2034-10-15 U-3506 Drug substance, Drug product 2023-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-004 9200002 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-004 9200002 2034-10-15 U-3506 Drug substance, Drug product 2021-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-004 9944651 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-004 9944651 2034-10-15 U-3506 Drug substance, Drug product 2021-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-004 9994575 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-004 9994575 2034-10-15 U-3506 Drug substance, Drug product 2021-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-004 11964980 2040-04-10 Drug substance, Drug product 2024-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-004 11999744 2040-04-10 U-3168 2024-06-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-004 11999744 2040-04-10 U-3506 2024-06-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-004 12252494 2040-04-10 U-3506 2025-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-005 9200002 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-005 9944651 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-005 9994575 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-005 11964980 2040-04-10 Drug substance, Drug product 2024-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-005 11999744 2040-04-10 U-3168 2024-06-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212608-001 9200002 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 21 · 828 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ayvakit
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVAPRITINIB 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 513P80B4YJ Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72064-120-30 Ayvakit 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72064-120 AYVAKIT (AVAPRITINIB) TABLET, FILM COATED [BLUEPRINT MEDICINES CORPORATION] 12 Current NDC, Legacy NDC, 1 package rows 20241121_645c887c-8cd4-4623-8da9-ac223d71a8b9.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 72064-120-30 72064012030 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72064-120-30) 2020-01-09 0000-00-00 No No Current