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: 0904-7809
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Cyclobenzaprine hydrochloride ( UNII: 0VE05JYS2P)( Cyclobenzaprine - UNII: 69O5WQQ5TI ) 10 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Croscarmellose sodium ( UNII: M28OL1HH48)
Anhydrous dibasic calcium phosphate ( UNII: L11K75P92J)
Hydroxypropyl cellulose (1600000 wamw) ( UNII: RFW2ET671P)
Hypromellose, unspecified ( UNII: 3NXW29V3WO)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color WHITE Size 8 mm
Shape ROUND Score 1
Imprint Code DAN;5658

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA071611 USA

Labeler - Major Pharmaceuticals( 191427277)

Package/label display panel

Cyclobenzaprine Hydrochloride Tablets, USP

10 mg

10 Tablets