BACLOFEN
Baclofen Tablets USP Rx only
Approved
Approval ID
4679a275-9307-4b0f-a2eb-2d83227ea84d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2021
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
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 Code59651-395
Application NumberANDA214099
Product Classification
M
Marketing Category
C73584
G
Generic Name
BACLOFEN
Product Specifications
Route of AdministrationORAL
Effective DateNovember 17, 2021
FDA Product Classification
INGREDIENTS (5)
BACLOFENActive
Quantity: 20 mg in 1 1
Code: H789N3FKE8
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSE 112Inactive
Code: X7XJ6RM9Q2
Classification: IACT
BACLOFEN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59651-394
Application NumberANDA214099
Product Classification
M
Marketing Category
C73584
G
Generic Name
BACLOFEN
Product Specifications
Route of AdministrationORAL
Effective DateNovember 17, 2021
FDA Product Classification
INGREDIENTS (5)
BACLOFENActive
Quantity: 10 mg in 1 1
Code: H789N3FKE8
Classification: ACTIB
MICROCRYSTALLINE CELLULOSE 112Inactive
Code: X7XJ6RM9Q2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT