Label: BACLOFEN tablet
- NDC Code(s): 80175-0006-3
- Packager: Central Packaging
- This is a repackaged label.
- Source NDC Code(s): 71930-006
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated February 22, 2021
If you are a consumer or patient please visit this version.
INDICATIONS & USAGE
Baclofen Tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen Tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases.
Baclofen Tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:80175-0006(NDC:71930-006) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 10 mg Product Characteristics Color white Score 2 pieces Shape ROUND Size 9mm Flavor Imprint Code E;6 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80175-0006-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/10/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211555 01/10/2020 Labeler - Central Packaging (117617671) Establishment Name Address ID/FEI Business Operations Central Packaging, LLC 117617671 repack(80175-0006)