Baclofen
BACLOFEN TABLETS, USP 5 mg, 10 mg and 20 mg Rx only
Approved
Approval ID
198a9d33-25de-4509-9f7d-166ce0c53a0c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 30, 2023
Manufacturers
FDA
Amneal Pharmaceuticals of New York LLC
DUNS: 123797875
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Baclofen
PRODUCT DETAILS
NDC Product Code0115-1011
Application NumberANDA077971
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 30, 2023
Generic NameBaclofen
INGREDIENTS (6)
BACLOFENActive
Quantity: 5 mg in 1 1
Code: H789N3FKE8
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
Baclofen
PRODUCT DETAILS
NDC Product Code0115-1010
Application NumberANDA077971
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 30, 2023
Generic NameBaclofen
INGREDIENTS (6)
BACLOFENActive
Quantity: 10 mg in 1 1
Code: H789N3FKE8
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Baclofen
PRODUCT DETAILS
NDC Product Code0115-1012
Application NumberANDA077971
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 30, 2023
Generic NameBaclofen
INGREDIENTS (6)
BACLOFENActive
Quantity: 20 mg in 1 1
Code: H789N3FKE8
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT