Home NDC 0078-0668-15 Mekinist
Product NDC 0078-0668
Requested package NDC 0078-0668-15
11-digit product format 000780668
Labeler code 0078
Product ID 0078-0668_58ebc072-df4c-4e0e-86ff-5c992a0ab1c1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name trametinib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Novartis Pharmaceuticals Corporation
Application NDA204114
Marketing category NDA
Marketing start 2016-03-17
Marketing end 0000-00-00
Substance TRAMETINIB DIMETHYL SULFOXIDE
Active strength 2 mg/1
Pharmacologic classes Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 10 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 2025-04-01 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N204114-001 MEKINIST TRAMETINIB DIMETHYL SULFOXIDE EQ 0.5MG TABLET / ORAL RLD 2013-05-29 N204114-002 MEKINIST TRAMETINIB DIMETHYL SULFOXIDE EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-29 N204114-003 MEKINIST TRAMETINIB DIMETHYL SULFOXIDE EQ 2MG TABLET / ORAL RLD, RS 2013-05-29
Orange Book patents# Current patent rows page 1 of 1 · 60 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N204114-001 7378423 2027-05-29 Drug substance, Drug product 2013-06-06 N204114-001 7378423*PED 2027-11-29 Pediatric extension N204114-001 8703781 2030-10-15 U-1712 Drug substance, Drug product 2015-05-22 N204114-001 8703781 2030-10-15 U-2020 Drug substance, Drug product 2015-05-22 N204114-001 8703781 2030-10-15 U-2037 Drug substance, Drug product 2015-05-22 N204114-001 8703781 2030-10-15 U-2302 Drug substance, Drug product 2015-05-22 N204114-001 8703781 2030-10-15 U-2305 Drug substance, Drug product 2015-05-22 N204114-001 8952018 2030-10-15 U-2020 2016-09-22 N204114-001 8703781*PED 2031-04-15 Pediatric extension N204114-001 8952018*PED 2031-04-15 Pediatric extension N204114-001 8580304 2032-01-28 Drug product N204114-001 9155706 2032-01-28 Drug product 2015-12-10 N204114-001 9271941 2032-01-28 Drug product 2016-04-08 N204114-001 9399021 2032-01-28 Drug product 2019-12-19 N204114-001 8580304*PED 2032-07-28 Pediatric extension N204114-001 9155706*PED 2032-07-28 Pediatric extension N204114-001 9271941*PED 2032-07-28 Pediatric extension N204114-001 9399021*PED 2032-07-28 Pediatric extension N204114-001 10869869 2033-08-30 U-3184 2021-08-18 N204114-001 10869869*PED 2034-02-28 Pediatric extension N204114-002 7378423 2027-05-29 Drug substance, Drug product N204114-002 7378423*PED 2027-11-29 Pediatric extension N204114-002 8703781 2030-10-15 U-1712 Drug substance, Drug product 2015-05-22 N204114-002 8703781 2030-10-15 U-2020 Drug substance, Drug product 2015-05-22 N204114-002 8703781 2030-10-15 U-2037 Drug substance, Drug product 2015-05-22 N204114-002 8703781 2030-10-15 U-2302 Drug substance, Drug product 2015-05-22 N204114-002 8703781 2030-10-15 U-2305 Drug substance, Drug product 2015-05-22 N204114-002 8952018 2030-10-15 U-2020 2016-09-22 N204114-002 8703781*PED 2031-04-15 Pediatric extension N204114-002 8952018*PED 2031-04-15 Pediatric extension N204114-002 8580304 2032-01-28 Drug product N204114-002 9155706 2032-01-28 Drug product 2016-09-22 N204114-002 9271941 2032-01-28 Drug product 2016-09-22 N204114-002 9399021 2032-01-28 Drug product 2019-12-19 N204114-002 8580304*PED 2032-07-28 Pediatric extension N204114-002 9155706*PED 2032-07-28 Pediatric extension N204114-002 9271941*PED 2032-07-28 Pediatric extension N204114-002 9399021*PED 2032-07-28 Pediatric extension N204114-002 10869869 2033-08-30 U-3184 2021-08-18 N204114-002 10869869*PED 2034-02-28 Pediatric extension N204114-003 7378423 2027-05-29 Drug substance, Drug product N204114-003 7378423*PED 2027-11-29 Pediatric extension N204114-003 8703781 2030-10-15 U-1712 Drug substance, Drug product 2015-05-22 N204114-003 8703781 2030-10-15 U-2020 Drug substance, Drug product 2015-05-22 N204114-003 8703781 2030-10-15 U-2037 Drug substance, Drug product 2015-05-22 N204114-003 8703781 2030-10-15 U-2302 Drug substance, Drug product 2015-05-22 N204114-003 8703781 2030-10-15 U-2305 Drug substance, Drug product 2015-05-22 N204114-003 8952018 2030-10-15 U-2020 2016-09-22 N204114-003 8703781*PED 2031-04-15 Pediatric extension N204114-003 8952018*PED 2031-04-15 Pediatric extension N204114-003 8580304 2032-01-28 Drug product 2013-12-10 N204114-003 9155706 2032-01-28 Drug product 2015-12-10 N204114-003 9271941 2032-01-28 Drug product 2016-04-08 N204114-003 9399021 2032-01-28 Drug product 2019-12-19 N204114-003 8580304*PED 2032-07-28 Pediatric extension N204114-003 9155706*PED 2032-07-28 Pediatric extension N204114-003 9271941*PED 2032-07-28 Pediatric extension N204114-003 9399021*PED 2032-07-28 Pediatric extension N204114-003 10869869 2033-08-30 U-3184 2021-08-18 N204114-003 10869869*PED 2034-02-28 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 12 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 4 · 123 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 N204114-001 MEKINIST EQ 0.5MG TABLET / ORAL RLD 2013-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-002 MEKINIST EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-003 MEKINIST EQ 2MG TABLET / ORAL RLD, RS 2013-05-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204114-001 MEKINIST EQ 0.5MG TABLET / ORAL RLD 2013-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204114-002 MEKINIST EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204114-003 MEKINIST EQ 2MG TABLET / ORAL RLD, RS 2013-05-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204114-001 MEKINIST EQ 0.5MG TABLET / ORAL RLD 2013-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204114-002 MEKINIST EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204114-003 MEKINIST EQ 2MG TABLET / ORAL RLD, RS 2013-05-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204114-001 MEKINIST EQ 0.5MG TABLET / ORAL RLD 2013-05-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204114-002 MEKINIST EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204114-003 MEKINIST EQ 2MG TABLET / ORAL RLD, RS 2013-05-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204114-001 MEKINIST EQ 0.5MG TABLET / ORAL RLD 2013-05-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204114-002 MEKINIST EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204114-003 MEKINIST EQ 2MG TABLET / ORAL RLD, RS 2013-05-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204114-001 MEKINIST EQ 0.5MG TABLET / ORAL RLD 2013-05-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204114-002 MEKINIST EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204114-003 MEKINIST EQ 2MG TABLET / ORAL RLD, RS 2013-05-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204114-001 MEKINIST EQ 0.5MG TABLET / ORAL RLD 2013-05-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204114-002 MEKINIST EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204114-003 MEKINIST EQ 2MG TABLET / ORAL RLD, RS 2013-05-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204114-001 MEKINIST EQ 0.5MG TABLET / ORAL RLD 2013-05-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204114-002 MEKINIST EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204114-003 MEKINIST EQ 2MG TABLET / ORAL RLD, RS 2013-05-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204114-001 MEKINIST EQ 0.5MG TABLET / ORAL RLD 2013-05-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204114-002 MEKINIST EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204114-003 MEKINIST EQ 2MG TABLET / ORAL RLD, RS 2013-05-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204114-001 MEKINIST EQ 0.5MG TABLET / ORAL RLD 2013-05-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204114-002 MEKINIST EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204114-003 MEKINIST EQ 2MG TABLET / ORAL RLD, RS 2013-05-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204114-001 MEKINIST EQ 0.5MG TABLET / ORAL AB RLD 2013-05-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204114-002 MEKINIST EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204114-003 MEKINIST EQ 2MG TABLET / ORAL AB RLD, RS 2013-05-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204114-001 MEKINIST EQ 0.5MG TABLET / ORAL RLD 2013-05-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204114-002 MEKINIST EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204114-003 MEKINIST EQ 2MG TABLET / ORAL RLD, RS 2013-05-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204114-001 MEKINIST EQ 0.5MG TABLET / ORAL RLD 2013-05-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204114-002 MEKINIST EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204114-003 MEKINIST EQ 2MG TABLET / ORAL RLD, RS 2013-05-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204114-001 MEKINIST EQ 0.5MG TABLET / ORAL RLD 2013-05-29 8072bd15b7f6…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204114-001 AB 1 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204114-003 AB 1 79d66fd596c7…
Observed Orange Book patent history# Patent history page 1 of 69 · 2,757 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 N204114-001 7378423 2027-05-29 Drug substance, Drug product 2013-06-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-001 7378423*PED 2027-11-29 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-001 8703781 2030-10-15 U-2305 Drug substance, Drug product 2015-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-001 8703781 2030-10-15 U-1712 Drug substance, Drug product 2015-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-001 8703781 2030-10-15 U-2020 Drug substance, Drug product 2015-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-001 8703781 2030-10-15 U-2302 Drug substance, Drug product 2015-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-001 8703781 2030-10-15 U-2037 Drug substance, Drug product 2015-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-001 8952018 2030-10-15 U-2020 2016-09-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-001 8703781*PED 2031-04-15 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-001 8952018*PED 2031-04-15 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-001 8580304 2032-01-28 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-001 9155706 2032-01-28 Drug product 2015-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-001 9271941 2032-01-28 Drug product 2016-04-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-001 9399021 2032-01-28 Drug product 2019-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-001 8580304*PED 2032-07-28 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-001 9155706*PED 2032-07-28 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-001 9271941*PED 2032-07-28 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-001 9399021*PED 2032-07-28 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-001 10869869 2033-08-30 U-3184 2021-08-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-001 10869869*PED 2034-02-28 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-002 7378423 2027-05-29 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-002 7378423*PED 2027-11-29 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-002 8703781 2030-10-15 U-2302 Drug substance, Drug product 2015-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-002 8703781 2030-10-15 U-2037 Drug substance, Drug product 2015-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-002 8703781 2030-10-15 U-1712 Drug substance, Drug product 2015-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-002 8703781 2030-10-15 U-2305 Drug substance, Drug product 2015-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-002 8703781 2030-10-15 U-2020 Drug substance, Drug product 2015-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-002 8952018 2030-10-15 U-2020 2016-09-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-002 8703781*PED 2031-04-15 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-002 8952018*PED 2031-04-15 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-002 8580304 2032-01-28 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-002 9155706 2032-01-28 Drug product 2016-09-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-002 9271941 2032-01-28 Drug product 2016-09-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-002 9399021 2032-01-28 Drug product 2019-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-002 8580304*PED 2032-07-28 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-002 9155706*PED 2032-07-28 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-002 9271941*PED 2032-07-28 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-002 9399021*PED 2032-07-28 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-002 10869869 2033-08-30 U-3184 2021-08-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204114-002 10869869*PED 2034-02-28 Pediatric extension 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 26 · 1,017 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mekinist TRAMETINIB Novartis Pharmaceuticals Corporation 0002ad27-779d-42ab-83b5-bc65453412a1 2026-05-07 Warnings, Adverse reactions Exact identifier application applno (NDA): 204114 application number: NDA204114
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0078-0668-15 00078066815 30 TABLET, FILM COATED in 1 BOTTLE (0078-0668-15) 2016-03-17 0000-00-00 No No Current