Home NDC 50242-717 Cotellic
Product NDC 50242-717
11-digit product format 502420717
Labeler code 50242
Product ID 50242-717_f3881f36-9b41-4c3c-a964-f7a3ecc932d1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name COBIMETINIB
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Genentech, Inc.
Application NDA206192
Marketing category NDA
Marketing start 2015-11-10
Substance COBIMETINIB FUMARATE
Active strength 20 mg/1
Pharmacologic classes Kinase Inhibitor [EPC], 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N206192-001 COTELLIC COBIMETINIB FUMARATE EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10
Orange Book patents# Current patent rows page 1 of 1 · 13 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206192-001 11597699 2026-10-05 U-3554 2023-03-29 N206192-001 8362002 2026-10-05 U-1776 2015-12-09 N206192-001 8362002*PED 2027-04-05 Pediatric extension N206192-001 7803839 2029-11-10 Drug substance, Drug product 2015-12-09 N206192-001 7803839*PED 2030-05-10 Pediatric extension N206192-001 11087354 2034-06-22 U-1776 2021-09-08 N206192-001 11087354*PED 2034-12-22 Pediatric extension N206192-001 10478400 2036-06-29 U-1776 Drug substance, Drug product 2019-12-18 N206192-001 10590102 2036-06-30 U-1776 Drug substance, Drug product 2020-04-08 N206192-001 11254649 2036-06-30 U-1776 Drug substance, Drug product 2022-03-21 N206192-001 10478400*PED 2036-12-29 Pediatric extension N206192-001 10590102*PED 2036-12-30 Pediatric extension N206192-001 11254649*PED 2036-12-30 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N206192-001 M-278 2025-07-28 N206192-001 PED 2026-01-28 N206192-001 ODE-416 2029-10-28
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 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N206192-001 COTELLIC EQ 20MG BASE TABLET / ORAL RLD, RS 2015-11-10 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 11 · 404 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 N206192-001 11597699 2026-10-05 U-3554 2023-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206192-001 8362002 2026-10-05 U-1776 2015-12-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206192-001 8362002*PED 2027-04-05 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206192-001 7803839 2029-11-10 Drug substance, Drug product 2015-12-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206192-001 7803839*PED 2030-05-10 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206192-001 11087354 2034-06-22 U-1776 2021-09-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206192-001 11087354*PED 2034-12-22 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206192-001 10478400 2036-06-29 U-1776 Drug substance, Drug product 2019-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206192-001 10590102 2036-06-30 U-1776 Drug substance, Drug product 2020-04-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206192-001 11254649 2036-06-30 U-1776 Drug substance, Drug product 2022-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206192-001 10478400*PED 2036-12-29 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206192-001 10590102*PED 2036-12-30 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206192-001 11254649*PED 2036-12-30 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206192-001 11597699 2026-10-05 U-3554 2023-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206192-001 8362002 2026-10-05 U-1776 2015-12-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206192-001 8362002*PED 2027-04-05 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206192-001 7803839 2029-11-10 Drug substance, Drug product 2015-12-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206192-001 7803839*PED 2030-05-10 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206192-001 11087354 2034-06-22 U-1776 2021-09-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206192-001 11087354*PED 2034-12-22 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206192-001 10478400 2036-06-29 U-1776 Drug substance, Drug product 2019-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206192-001 10590102 2036-06-30 U-1776 Drug substance, Drug product 2020-04-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206192-001 11254649 2036-06-30 U-1776 Drug substance, Drug product 2022-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206192-001 10478400*PED 2036-12-29 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206192-001 10590102*PED 2036-12-30 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206192-001 11254649*PED 2036-12-30 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206192-001 11597699 2026-10-05 U-3554 2023-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206192-001 8362002 2026-10-05 U-1776 2015-12-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206192-001 8362002*PED 2027-04-05 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206192-001 7803839 2029-11-10 Drug substance, Drug product 2015-12-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206192-001 7803839*PED 2030-05-10 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206192-001 11087354 2034-06-22 U-1776 2021-09-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206192-001 11087354*PED 2034-12-22 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206192-001 10478400 2036-06-29 U-1776 Drug substance, Drug product 2019-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206192-001 10590102 2036-06-30 U-1776 Drug substance, Drug product 2020-04-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206192-001 11254649 2036-06-30 U-1776 Drug substance, Drug product 2022-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206192-001 10478400*PED 2036-12-29 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206192-001 10590102*PED 2036-12-30 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206192-001 11254649*PED 2036-12-30 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206192-001 11597699 2026-10-05 U-3554 2023-03-29 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 121 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Cotellic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength COBIMETINIB FUMARATE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6EXI96H8SV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1722370 Internal RxNorm lookup 1722376 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 50242-717-01 Cotellic 63 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 63 23
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded COBIMETINIB FUMARATE ACTIVE INGREDIENT 6EXI96H8SV COTELLIC (COBIMETINIB) TABLET, FILM COATED [GENENTECH, INC.] 1 COBIMETINIB ACTIVE MOIETY ER29L26N1X COTELLIC (COBIMETINIB) TABLET, FILM COATED [GENENTECH, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U COTELLIC (COBIMETINIB) TABLET, FILM COATED [GENENTECH, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 COTELLIC (COBIMETINIB) TABLET, FILM COATED [GENENTECH, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X COTELLIC (COBIMETINIB) TABLET, FILM COATED [GENENTECH, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 COTELLIC (COBIMETINIB) TABLET, FILM COATED [GENENTECH, INC.] 1 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P COTELLIC (COBIMETINIB) TABLET, FILM COATED [GENENTECH, INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A COTELLIC (COBIMETINIB) TABLET, FILM COATED [GENENTECH, INC.] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 COTELLIC (COBIMETINIB) TABLET, FILM COATED [GENENTECH, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U COTELLIC (COBIMETINIB) TABLET, FILM COATED [GENENTECH, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP COTELLIC (COBIMETINIB) TABLET, FILM COATED [GENENTECH, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R COTELLIC (COBIMETINIB) TABLET, FILM COATED [GENENTECH, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50242-717 COTELLIC (COBIMETINIB) TABLET, FILM COATED [GENENTECH, INC.] 20 Current NDC, Legacy NDC, 1 package rows 20241123_c387579e-cee0-4334-bd1e-73f93ac1bde6.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 50242-717-01 50242071701 63 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50242-717-01) 2015-11-10 0000-00-00 No No Current 50242-717-86 50242071786 63 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50242-717-86) 2015-11-10 0000-00-00 Yes No Current