Home NDC 0078-1161 Mekinist
Product NDC 0078-1161
11-digit product format 000781161
Labeler code 0078
Product ID 0078-1161_235e3bc1-099b-4587-9d72-b02fcc3387d1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name trametinib
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Novartis Pharmaceuticals Corporation
Application NDA217513
Marketing category NDA
Marketing start 2023-03-16
Substance TRAMETINIB DIMETHYL SULFOXIDE
Active strength .05 mg/mL
Pharmacologic classes Kinase Inhibitor [EPC], Protein 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 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 N217513-001 MEKINIST TRAMETINIB DIMETHYL SULFOXIDE EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217513-001 7378423 2027-05-29 Drug substance, Drug product 2023-05-04 N217513-001 7378423*PED 2027-11-29 Pediatric extension N217513-001 8703781 2030-10-15 U-3564 Drug substance, Drug product 2023-05-04 N217513-001 8703781*PED 2031-04-15 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 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.
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 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217513-001 MEKINIST EQ 0.05MG BASE/ML SOLUTION / ORAL RLD, RS 2023-03-16 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 95 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 N217513-001 7378423 2027-05-29 Drug substance, Drug product 2023-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217513-001 7378423*PED 2027-11-29 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217513-001 8703781 2030-10-15 U-3564 Drug substance, Drug product 2023-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217513-001 8703781*PED 2031-04-15 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217513-001 8835443 2025-06-10 U-3564 2023-05-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217513-001 8835443*PED 2025-12-10 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217513-001 7378423 2027-05-29 Drug substance, Drug product 2023-05-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217513-001 7378423*PED 2027-11-29 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217513-001 8703781 2030-10-15 U-3564 Drug substance, Drug product 2023-05-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217513-001 8703781*PED 2031-04-15 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217513-001 8835443 2025-06-10 U-3564 2023-05-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217513-001 8835443*PED 2025-12-10 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217513-001 7378423 2027-05-29 Drug substance, Drug product 2023-05-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217513-001 7378423*PED 2027-11-29 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217513-001 8703781 2030-10-15 U-3564 Drug substance, Drug product 2023-05-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217513-001 8703781*PED 2031-04-15 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217513-001 8835443 2025-06-10 U-3564 2023-05-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217513-001 8835443*PED 2025-12-10 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217513-001 7378423 2027-05-29 Drug substance, Drug product 2023-05-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217513-001 7378423*PED 2027-11-29 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217513-001 8703781 2030-10-15 U-3564 Drug substance, Drug product 2023-05-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217513-001 8703781*PED 2031-04-15 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217513-001 8835443 2025-06-10 U-3564 2023-05-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217513-001 8835443*PED 2025-12-10 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217513-001 7378423 2027-05-29 Drug substance, Drug product 2023-05-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217513-001 7378423*PED 2027-11-29 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217513-001 8703781 2030-10-15 U-3564 Drug substance, Drug product 2023-05-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217513-001 8703781*PED 2031-04-15 Pediatric extension b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217513-001 8835443 2025-06-10 U-3564 2023-05-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217513-001 8835443*PED 2025-12-10 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217513-001 7378423 2027-05-29 Drug substance, Drug product 2023-05-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217513-001 7378423*PED 2027-11-29 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217513-001 8703781 2030-10-15 U-3564 Drug substance, Drug product 2023-05-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217513-001 8703781*PED 2031-04-15 Pediatric extension 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217513-001 8835443 2025-06-10 U-3564 2023-05-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217513-001 8835443*PED 2025-12-10 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217513-001 7378423 2027-05-29 Drug substance, Drug product 2023-05-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217513-001 7378423*PED 2027-11-29 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217513-001 8703781 2030-10-15 U-3564 Drug substance, Drug product 2023-05-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217513-001 8703781*PED 2031-04-15 Pediatric extension 2680178bc6a6…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 66 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Mekinist
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRAMETINIB DIMETHYL SULFOXIDE .05 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BSB9VJ5TUT Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1425110 Internal RxNorm lookup 1425116 Internal RxNorm lookup 1425118 Internal RxNorm lookup 2632560 Internal RxNorm lookup 2632564 Internal RxNorm lookup 1425104 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 0078-1161-47 Mekinist 90 mL in 1 BOTTLE POWDER, FOR SOLUTION 90 35
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-1161 MEKINIST (TRAMETINIB) TABLET, FILM COATED MEKINIST (TRAMETINIB) POWDER, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 30 Current NDC, 1 package rows 20250412_0002ad27-779d-42ab-83b5-bc65453412a1.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 Sample Exclude flag Status 0078-1161-47 00078116147 90 mL in 1 BOTTLE (0078-1161-47) 90 ml 2023-03-16 No No Current