CYCLOBENZAPRINE HYDROCHLORIDE- cyclobenzaprine hydrochloride tablet, film coated 
Central Packaging

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Cyclobenzaprine hydrochloride tablets are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.

Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.

Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.

Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.

Cyclobenzaprine Hydro Bottle

CYCLOBENZAPRINE HYDROCHLORIDE 
cyclobenzaprine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:80175-0400(NDC:43547-400)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CYCLOBENZAPRINE HYDROCHLORIDE (UNII: 0VE05JYS2P) (CYCLOBENZAPRINE - UNII:69O5WQQ5TI) CYCLOBENZAPRINE HYDROCHLORIDE10 mg
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize7mm
FlavorImprint Code 2632;V
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80175-0400-330 in 1 BOTTLE; Type 0: Not a Combination Product03/30/2017
2NDC:80175-0400-660 in 1 BOTTLE; Type 0: Not a Combination Product03/30/2017
3NDC:80175-0400-990 in 1 BOTTLE; Type 0: Not a Combination Product03/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07779703/30/2017
Labeler - Central Packaging (117617671)
Establishment
NameAddressID/FEIBusiness Operations
Central Packaging, LLC117617671repack(80175-0400)

Revised: 2/2021
Document Id: bbb67b5b-d96c-9eca-e053-2a95a90ab5af
Set id: bbb67b5b-d96b-9eca-e053-2a95a90ab5af
Version: 1
Effective Time: 20210219
 
Central Packaging