NDC Code(s) : 52125-019-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

cyclobenzaprine hydrochloridecyclobenzaprine hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-019(NDC:59746-177)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLOBENZAPRINE HYDROCHLORIDE(UNII: 0VE05JYS2P)
(CYCLOBENZAPRINE - UNII:69O5WQQ5TI) 		CYCLOBENZAPRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 1000000(UNII: HZ58M6D839)
POLYVINYL ALCOHOL(UNII: 532B59J990)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color yellow Score no score
Shape ROUND (TABLET) Size 7 mm
Flavor Imprint Code TL177
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-019-0230 in 1 BLISTER PACK Type 0: Not a Combination Product19/07/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077563 07/19/2012 07/20/2013

PRINCIPAL DISPLAY PANEL

DRUG: cyclobenzaprine hydrochloride

GENERIC: cyclobenzaprine hydrochloride

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 52125-019-02

STRENGTH:10 mg

COLOR: yellow

SHAPE: ROUND

SCORE: No score

SIZE: 7 mm

IMPRINT: 30

QTY: 30



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