cotellic

Generic: cobimetinib

Labeler: genentech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cotellic
Generic Name cobimetinib
Labeler genentech, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cobimetinib fumarate 20 mg/1

Manufacturer
Genentech, Inc.

Identifiers & Regulatory

Product NDC 50242-717
Product ID 50242-717_f3881f36-9b41-4c3c-a964-f7a3ecc932d1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA206192
Listing Expiration 2026-12-31
Marketing Start 2015-11-10

Pharmacologic Class

Classes
kinase inhibitor [epc] kinase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50242717
Hyphenated Format 50242-717

Supplemental Identifiers

RxCUI
1722370 1722376
UNII
6EXI96H8SV

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 cotellic (source: ndc)
Generic Name cobimetinib (source: ndc)
Application Number NDA206192 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 63 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50242-717-01)
source: ndc

Packages (1)

50242-717-01 63 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50242-717-01)

Ingredients (1)

cobimetinib fumarate (20 mg/1)

Linked Drug Pages (1)

Cotellic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f3881f36-9b41-4c3c-a964-f7a3ecc932d1", "openfda": {"unii": ["6EXI96H8SV"], "rxcui": ["1722370", "1722376"], "spl_set_id": ["c387579e-cee0-4334-bd1e-73f93ac1bde6"], "manufacturer_name": ["Genentech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "63 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50242-717-01)", "package_ndc": "50242-717-01", "marketing_start_date": "20151110"}], "brand_name": "Cotellic", "product_id": "50242-717_f3881f36-9b41-4c3c-a964-f7a3ecc932d1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Kinase Inhibitors [MoA]"], "product_ndc": "50242-717", "generic_name": "COBIMETINIB", "labeler_name": "Genentech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cotellic", "active_ingredients": [{"name": "COBIMETINIB FUMARATE", "strength": "20 mg/1"}], "application_number": "NDA206192", "marketing_category": "NDA", "marketing_start_date": "20151110", "listing_expiration_date": "20261231"}