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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0115-1011
Application NumberANDA077971
Product Classification
M
Marketing Category
C73584
G
Generic Name
Baclofen
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0115-1010
Application NumberANDA077971
Product Classification
M
Marketing Category
C73584
G
Generic Name
Baclofen
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0115-1012
Application NumberANDA077971
Product Classification
M
Marketing Category
C73584
G
Generic Name
Baclofen
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2023
FDA Product Classification
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