BACLOFEN
BACLOFEN TABLETS, USP Rx only
Approved
Approval ID
1f09dd74-b63a-4dec-82ff-4a53df433c43
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 20, 2024
Manufacturers
FDA
Graviti Pharmaceuticals Private Limited
DUNS: 650884781
Products 2
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 Code69844-085
Application NumberANDA217788
Product Classification
M
Marketing Category
C73584
G
Generic Name
baclofen
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2024
FDA Product Classification
INGREDIENTS (6)
BACLOFENActive
Quantity: 10 mg in 1 1
Code: H789N3FKE8
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
baclofen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69844-086
Application NumberANDA217788
Product Classification
M
Marketing Category
C73584
G
Generic Name
baclofen
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2024
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
BACLOFENActive
Quantity: 20 mg in 1 1
Code: H789N3FKE8
Classification: ACTIB