Baclofen
Baclofen 20mg Tablets
Approved
Approval ID
c85a9d82-1d61-aeec-e053-2995a90a03a4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2022
Manufacturers
FDA
Advanced Rx Pharmacy of Tennessee, LLC
DUNS: 117023142
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Baclofen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code80425-0157
Application NumberANDA209102
Product Classification
M
Marketing Category
C73584
G
Generic Name
Baclofen
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2022
FDA Product Classification
INGREDIENTS (1)
BACLOFENActive
Quantity: 20 mg in 1 1
Code: H789N3FKE8
Classification: ACTIB