Cyclobenzaprine hydrochloride tablet, film coated

Ingredients and appearance - Product information

Cyclobenzaprine hydrochloride tablet, film coated- Cyclobenzaprine hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 68788-7131
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Cyclobenzaprine hydrochloride ( UNII: 0VE05JYS2P)( Cyclobenzaprine - UNII: 69O5WQQ5TI ) 5 mgin 1

Inactive Ingredients

Ingredient Name Code
Croscarmellose sodium ( UNII: M28OL1HH48)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Hypromellose, unspecified ( UNII: 3NXW29V3WO)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Titanium dioxide ( UNII: 15FIX9V2JP)
Fd&c red no. 40 ( UNII: WZB9127XOA)

Product Characteristics

Color ORANGE Size 7 mm
Shape ROUND Score 1
Imprint Code 2631;V

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA077797 USA

Labeler - Preferred Pharmaceuticals Inc.( 791119022)

Establishment

Name ID/FEI Business Operations
Preferred Pharmaceuticals Inc. 791119022 REPACK( 68788-7131)