Label: CYCLOBENZAPRINE HYDROCHLORIDE tablet, film coated
- NDC Code(s): 80175-0400-3, 80175-0400-6, 80175-0400-9
- Packager: Central Packaging
- This is a repackaged label.
- Source NDC Code(s): 43547-400
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 19, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
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 coatedProduct 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)
