mekinist

Generic: trametinib

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name mekinist
Generic Name trametinib
Labeler novartis pharmaceuticals corporation
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

trametinib dimethyl sulfoxide .05 mg/mL

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-1161
Product ID 0078-1161_79c3da5e-f442-46a6-8580-ffc85fad1a09
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA217513
Listing Expiration 2027-12-31
Marketing Start 2023-03-16

Pharmacologic Class

Classes
kinase inhibitor [epc] protein kinase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00781161
Hyphenated Format 0078-1161

Supplemental Identifiers

RxCUI
1425116 1425118 2632560 1425104 2632564 1425110
UNII
BSB9VJ5TUT

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name mekinist (source: ndc)
Generic Name trametinib (source: ndc)
Application Number NDA217513 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .05 mg/mL
source: ndc
Packaging
  • 90 mL in 1 BOTTLE (0078-1161-47)
source: ndc

Packages (1)

0078-1161-47 90 mL in 1 BOTTLE (0078-1161-47)

Ingredients (1)

trametinib dimethyl sulfoxide (.05 mg/mL)

Linked Drug Pages (1)

Mekinist ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "79c3da5e-f442-46a6-8580-ffc85fad1a09", "openfda": {"unii": ["BSB9VJ5TUT"], "rxcui": ["1425116", "1425118", "2632560", "1425104", "2632564", "1425110"], "spl_set_id": ["0002ad27-779d-42ab-83b5-bc65453412a1"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 mL in 1 BOTTLE (0078-1161-47)", "package_ndc": "0078-1161-47", "marketing_start_date": "20230316"}], "brand_name": "Mekinist", "product_id": "0078-1161_79c3da5e-f442-46a6-8580-ffc85fad1a09", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "0078-1161", "generic_name": "trametinib", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mekinist", "active_ingredients": [{"name": "TRAMETINIB DIMETHYL SULFOXIDE", "strength": ".05 mg/mL"}], "application_number": "NDA217513", "marketing_category": "NDA", "marketing_start_date": "20230316", "listing_expiration_date": "20271231"}