NDC 50242-717
Cotellic
Cobimetinib
Cotellic is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Cobimetinib Fumarate.
| Product ID | 50242-717_29fb8757-a2d6-48d4-aa11-752d0ea8d5e2 |
| NDC | 50242-717 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Cotellic |
| Generic Name | Cobimetinib |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2015-11-10 |
| Marketing Category | NDA / NDA |
| Application Number | NDA206192 |
| Labeler Name | Genentech, Inc. |
| Substance Name | COBIMETINIB FUMARATE |
| Active Ingredient Strength | 20 mg/1 |
| Pharm Classes | Kinase Inhibitor [EPC], Kinase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
Packaging
NDC 50242-717-01
63 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50242-717-01)
| Marketing Start Date | 2015-11-10 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 50242-717-01 [50242071701]
Cotellic TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA206192 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-11-10 |
NDC 50242-717-86 [50242071786]
Cotellic TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA206192 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2015-11-10 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| COBIMETINIB FUMARATE | 20 mg/1 |
OpenFDA Data
| SPL SET ID: | c387579e-cee0-4334-bd1e-73f93ac1bde6 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Kinase Inhibitor [EPC]
- Kinase Inhibitors [MoA]
Trademark Results [Cotellic]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COTELLIC 86305545 4914506 Live/Registered |
GENENTECH, INC. 2014-06-10 |
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