Baclofen
BACLOFEN TABLETS USP Rx only
Approved
Approval ID
7ec59f6b-7c4f-432d-ba27-442861806b6c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 11, 2022
Manufacturers
FDA
Eywa Pharma Inc
DUNS: 080465609
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 Code71930-066
Application NumberANDA211555
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 11, 2022
Generic NameBaclofen
INGREDIENTS (8)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
BACLOFENActive
Quantity: 5 mg in 1 1
Code: H789N3FKE8
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Baclofen
PRODUCT DETAILS
NDC Product Code71930-006
Application NumberANDA211555
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 11, 2022
Generic NameBaclofen
INGREDIENTS (8)
BACLOFENActive
Quantity: 10 mg in 1 1
Code: H789N3FKE8
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Baclofen
PRODUCT DETAILS
NDC Product Code71930-007
Application NumberANDA211555
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 11, 2022
Generic NameBaclofen
INGREDIENTS (8)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
BACLOFENActive
Quantity: 20 mg in 1 1
Code: H789N3FKE8
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT