CYCLOBENZAPRINE HYDROCHLORIDE tablet, film coated

Cyclobenzaprine Hydrochloride by

Drug Labeling and Warnings

Cyclobenzaprine Hydrochloride by is a Prescription medication manufactured, distributed, or labeled by Central Packaging, Central Packaging, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CYCLOBENZAPRINE HYDROCHLORIDE 
cyclobenzaprine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 80175-0400(NDC:43547-400)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CYCLOBENZAPRINE HYDROCHLORIDE (UNII: 0VE05JYS2P) (CYCLOBENZAPRINE - UNII:69O5WQQ5TI)	CYCLOBENZAPRINE HYDROCHLORIDE	10 mg

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	2632;V
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80175-0400-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2017
2	NDC: 80175-0400-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2017
3	NDC: 80175-0400-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077797	03/30/2017

Labeler - Central Packaging (117617671)

Establishment
Name	Address	ID/FEI	Business Operations
Central Packaging, LLC		117617671	repack(80175-0400)