Cotellic (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — 63 Tablet Bottle Label

NDC 50242-717-01

Cotellic ®
(cobimetinib)
tablets

20 mg

Rx only

63 tabletsGenentech

10176377

PRINCIPAL DISPLAY PANEL -- 63 Tablet Bottle Label
(click image for full-size original)
COTELLIC cobimetinib tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50242-717
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COBIMETINIB FUMARATE (COBIMETINIB) COBIMETINIB 20 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
LACTOSE MONOHYDRATE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 3350
TALC
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code COB
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50242-717-01 63 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:50242-717-86 63 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206192 11/10/2015
Labeler — Genentech, Inc. (080129000)
Establishment
Name Address ID/FEI Operations
Genentech, Inc. 080129000 ANALYSIS (50242-717), API MANUFACTURE (50242-717)
Establishment
Name Address ID/FEI Operations
F. Hoffmann-La Roche AG 482242971 API MANUFACTURE (50242-717), ANALYSIS (50242-717), MANUFACTURE (50242-717)
Establishment
Name Address ID/FEI Operations
F. Hoffmann-La Roche Ltd. 485244961 ANALYSIS (50242-717)

Revised: 06/2023 Genentech, Inc.

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