Home NDC 70255-010 MEKTOVI
Product NDC 70255-010
11-digit product format 702550010
Labeler code 70255
Product ID 70255-010_36941d95-638d-4a3c-8888-209eea0e0722
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name BINIMETINIB
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Array BioPharma Inc.
Application NDA210498
Marketing category NDA
Marketing start 2018-06-27
Substance BINIMETINIB
Active strength 15 mg/1
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N210498-001 MEKTOVI BINIMETINIB 15MG TABLET / ORAL RLD, RS 2018-06-27
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 N210498-001 7777050 2027-03-13 Drug substance, Drug product 2018-07-25 N210498-001 10005761 2030-08-27 U-2331 2018-07-25 N210498-001 10005761 2030-08-27 U-3737 2018-07-25 N210498-001 9850229 2030-08-27 U-2333 2018-07-25 N210498-001 9314464 2031-07-04 U-2332 2018-07-25 N210498-001 9314464 2031-07-04 U-3737 2018-07-25 N210498-001 9562016 2033-10-18 Drug substance, Drug product 2018-07-25 N210498-001 9598376 2033-10-18 U-2330 2018-07-25 N210498-001 9980944 2033-10-18 U-2334 2018-07-25
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N210498-001 I-928 2026-10-11
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 2 · 41 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 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N210498-001 MEKTOVI 15MG TABLET / ORAL RLD, RS 2018-06-27 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 11 · 407 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 N210498-001 7777050 2026-03-13 Drug substance, Drug product 2018-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210498-001 10005761 2030-08-27 U-2331 2018-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210498-001 10005761 2030-08-27 U-3737 2018-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210498-001 9850229 2030-08-27 U-2333 2018-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210498-001 9314464 2031-07-04 U-2332 2018-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210498-001 9314464 2031-07-04 U-3737 2018-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210498-001 9562016 2033-10-18 Drug substance, Drug product 2018-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210498-001 9598376 2033-10-18 U-2330 2018-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210498-001 9980944 2033-10-18 U-2334 2018-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210498-001 7777050 2026-03-13 Drug substance, Drug product 2018-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210498-001 10005761 2030-08-27 U-2331 2018-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210498-001 10005761 2030-08-27 U-3737 2018-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210498-001 9850229 2030-08-27 U-2333 2018-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210498-001 9314464 2031-07-04 U-2332 2018-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210498-001 9314464 2031-07-04 U-3737 2018-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210498-001 9562016 2033-10-18 Drug substance, Drug product 2018-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210498-001 9598376 2033-10-18 U-2330 2018-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210498-001 9980944 2033-10-18 U-2334 2018-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210498-001 7777050 2026-03-13 Drug substance, Drug product 2018-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210498-001 10005761 2030-08-27 U-2331 2018-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210498-001 10005761 2030-08-27 U-3737 2018-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210498-001 9850229 2030-08-27 U-2333 2018-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210498-001 9314464 2031-07-04 U-2332 2018-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210498-001 9314464 2031-07-04 U-3737 2018-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210498-001 9562016 2033-10-18 Drug substance, Drug product 2018-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210498-001 9598376 2033-10-18 U-2330 2018-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210498-001 9980944 2033-10-18 U-2334 2018-07-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210498-001 7777050 2025-03-13 Drug substance, Drug product 2018-07-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210498-001 10005761 2030-08-27 U-2331 2018-07-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210498-001 10005761 2030-08-27 U-3737 2018-07-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210498-001 9850229 2030-08-27 U-2333 2018-07-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210498-001 9314464 2031-07-04 U-2332 2018-07-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210498-001 9314464 2031-07-04 U-3737 2018-07-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210498-001 9562016 2033-10-18 Drug substance, Drug product 2018-07-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210498-001 9598376 2033-10-18 U-2330 2018-07-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210498-001 9980944 2033-10-18 U-2334 2018-07-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210498-001 7777050 2025-03-13 Drug substance, Drug product 2018-07-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210498-001 10005761 2030-08-27 U-2331 2018-07-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210498-001 10005761 2030-08-27 U-3737 2018-07-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210498-001 9850229 2030-08-27 U-2333 2018-07-25 b8a1b40f171c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 80 observed states.
Additional Listing Data#
Finished product Yes
Brand name base MEKTOVI
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BINIMETINIB 15 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 181R97MR71 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2049127 Internal RxNorm lookup 2049133 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70255-010-02 MEKTOVI 180 in 1 BOTTLE TABLET, FILM COATED 180 12 70255-010-02 MEKTOVI 1 in 1 CARTON TABLET, FILM COATED 1 12 70255-010-03 MEKTOVI 90 in 1 BOTTLE TABLET, FILM COATED 90 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70255-010 MEKTOVI (BINIMETINIB) TABLET, FILM COATED [ARRAY BIOPHARMA INC.] 12 Current NDC, Legacy NDC, 3 package rows 20250323_6c3408ac-d401-4925-8a03-26591afbc240.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 Units Marketing start Marketing end Sample Exclude flag Status 70255-010-02 70255001002 1 BOTTLE in 1 CARTON (70255-010-02) / 180 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2018-06-27 0000-00-00 No No Current 70255-010-03 70255001003 90 TABLET, FILM COATED in 1 BOTTLE (70255-010-03) 2018-06-27 0000-00-00 No No Current