Baclofen
Baclofen Tablets, USP Rx only
Approved
Approval ID
290659aa-e1fd-42d7-99a5-8b1063eab657
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 4, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-5838
Application NumberANDA212378
Product Classification
M
Marketing Category
C73584
G
Generic Name
Baclofen
Product Specifications
Route of AdministrationORAL
Effective DateOctober 5, 2021
FDA Product Classification
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
BACLOFENActive
Quantity: 20 mg in 1 1
Code: H789N3FKE8
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ZINC STEARATEInactive
Code: H92E6QA4FV
Classification: IACT