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
NDC Product Code50090-5838
Application NumberANDA212378
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 5, 2021
Generic NameBaclofen
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