BACLOFEN
BACLOFEN TABLETS, USP
Approved
Approval ID
68aa591e-ea98-4438-9a4a-4f7e9ea2b285
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 14, 2021
Manufacturers
FDA
TruPharma LLC
DUNS: 078533947
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 Code52817-320
Application NumberANDA209102
Product Classification
M
Marketing Category
C73584
G
Generic Name
BACLOFEN
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 14, 2021
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
BACLOFENActive
Quantity: 10 mg in 1 1
Code: H789N3FKE8
Classification: ACTIB
BACLOFEN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52817-319
Application NumberANDA209102
Product Classification
M
Marketing Category
C73584
G
Generic Name
BACLOFEN
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 14, 2021
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
BACLOFENActive
Quantity: 5 mg in 1 1
Code: H789N3FKE8
Classification: ACTIB
BACLOFEN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52817-321
Application NumberANDA209102
Product Classification
M
Marketing Category
C73584
G
Generic Name
BACLOFEN
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 14, 2021
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
BACLOFENActive
Quantity: 20 mg in 1 1
Code: H789N3FKE8
Classification: ACTIB