Home NDC 72064-120 Ayvakit
Product NDC 72064-120
11-digit product format 720640120
Labeler code 72064
Product ID 72064-120_c6bf8968-b0ec-46f8-91ca-f73ff9b1f1c1
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 187 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 2026-09-14 22:38:34 2026-08 N212608-001 AYVAKIT 100MG TABLET / ORAL RLD 2020-01-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-002 AYVAKIT 200MG TABLET / ORAL RLD 2020-01-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-003 AYVAKIT 300MG TABLET / ORAL RLD, RS 2020-01-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-004 AYVAKIT 25MG TABLET / ORAL RLD 2021-06-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-005 AYVAKIT 50MG TABLET / ORAL RLD 2021-06-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N212608-001 AYVAKIT 100MG TABLET / ORAL RLD 2020-01-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212608-002 AYVAKIT 200MG TABLET / ORAL RLD 2020-01-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212608-003 AYVAKIT 300MG TABLET / ORAL RLD, RS 2020-01-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212608-004 AYVAKIT 25MG TABLET / ORAL RLD 2021-06-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212608-005 AYVAKIT 50MG TABLET / ORAL RLD 2021-06-16 caaa826d4ba7…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…
Observed Orange Book patent history# Patent history page 1 of 27 · 1,069 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 N212608-001 9200002 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-001 9200002 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-001 9944651 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-001 9944651 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-001 9994575 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-001 9994575 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-001 11964980 2040-04-10 Drug substance, Drug product 2024-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-001 11999744 2040-04-10 U-3168 2024-06-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-001 12060354 2042-03-08 U-2726 2024-08-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-002 9200002 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-002 9200002 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-002 9944651 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-002 9944651 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-002 9994575 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-002 9994575 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-002 11964980 2040-04-10 Drug substance, Drug product 2024-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-002 11999744 2040-04-10 U-3168 2024-06-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-002 12060354 2042-03-08 U-2726 2024-08-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-003 9200002 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-003 9944651 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-003 9994575 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-003 11964980 2040-04-10 Drug substance, Drug product 2024-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-003 12060354 2042-03-08 U-2726 2024-08-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-004 11827642 2034-10-15 U-3506 Drug substance, Drug product 2023-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-004 9200002 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-004 9200002 2034-10-15 U-3506 Drug substance, Drug product 2021-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-004 9944651 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-004 9944651 2034-10-15 U-3506 Drug substance, Drug product 2021-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-004 9994575 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-004 9994575 2034-10-15 U-3506 Drug substance, Drug product 2021-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-004 11964980 2040-04-10 Drug substance, Drug product 2024-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-004 11999744 2040-04-10 U-3168 2024-06-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-004 11999744 2040-04-10 U-3506 2024-06-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-004 12252494 2040-04-10 U-3506 2025-04-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-005 9200002 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-005 9944651 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-005 9994575 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-005 11964980 2040-04-10 Drug substance, Drug product 2024-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-005 11999744 2040-04-10 U-3168 2024-06-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 N212608-001 9200002 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 22 · 860 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
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
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