BACLOFEN- baclofen tablet 
Central Packaging

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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.

Baclofen Bottle

BACLOFEN 
baclofen tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:80175-0006(NDC:71930-006)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN10 mg
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize9mm
FlavorImprint Code E;6
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80175-0006-330 in 1 BOTTLE; Type 0: Not a Combination Product01/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21155501/10/2020
Labeler - Central Packaging (117617671)
Establishment
NameAddressID/FEIBusiness Operations
Central Packaging, LLC117617671repack(80175-0006)

Revised: 2/2021
Document Id: bbf3a739-13d8-4667-e053-2a95a90a1eca
Set id: bbf3a739-13d7-4667-e053-2a95a90a1eca
Version: 1
Effective Time: 20210222
 
Central Packaging