Cotellic
- Product NDC
- 50242-717
- 11-digit product format
- 502420717
- Labeler code
- 50242
- Product ID
- 50242-717_f3881f36-9b41-4c3c-a964-f7a3ecc932d1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- COBIMETINIB
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Genentech, Inc.
- Application
- NDA206192
- Marketing category
- NDA
- Marketing start
- 2015-11-10
- Substance
- COBIMETINIB FUMARATE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cotellic
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| COBIMETINIB FUMARATE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6EXI96H8SV |
| Rxcui | 1722370, 1722376 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50242-717-01 | Cotellic | 63 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 63 | | 23 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| COBIMETINIB FUMARATE | ACTIVE INGREDIENT | 6EXI96H8SV | COTELLIC (COBIMETINIB) TABLET, FILM COATED [GENENTECH, INC.] | 1 | |
| COBIMETINIB | ACTIVE MOIETY | ER29L26N1X | COTELLIC (COBIMETINIB) TABLET, FILM COATED [GENENTECH, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | COTELLIC (COBIMETINIB) TABLET, FILM COATED [GENENTECH, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | COTELLIC (COBIMETINIB) TABLET, FILM COATED [GENENTECH, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | COTELLIC (COBIMETINIB) TABLET, FILM COATED [GENENTECH, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | COTELLIC (COBIMETINIB) TABLET, FILM COATED [GENENTECH, INC.] | 1 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | COTELLIC (COBIMETINIB) TABLET, FILM COATED [GENENTECH, INC.] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | COTELLIC (COBIMETINIB) TABLET, FILM COATED [GENENTECH, INC.] | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | COTELLIC (COBIMETINIB) TABLET, FILM COATED [GENENTECH, INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | COTELLIC (COBIMETINIB) TABLET, FILM COATED [GENENTECH, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | COTELLIC (COBIMETINIB) TABLET, FILM COATED [GENENTECH, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | COTELLIC (COBIMETINIB) TABLET, FILM COATED [GENENTECH, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50242-717 | COTELLIC (COBIMETINIB) TABLET, FILM COATED [GENENTECH, INC.] | 20 | Current NDC, Legacy NDC, 1 package rows | 20241123_c387579e-cee0-4334-bd1e-73f93ac1bde6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50242-717-01 | 50242071701 | 63 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50242-717-01) | 2015-11-10 | 0000-00-00 | No | No | Current |
| 50242-717-86 | 50242071786 | 63 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50242-717-86) | 2015-11-10 | 0000-00-00 | Yes | No | Current |