BACLOFEN
These highlights do not include all the information needed to use BACLOFEN INJECTION safely and effectively. See full prescribing information for BACLOFEN INJECTION BACLOFEN injection, for intrathecal use Initial U.S. Approval: 1992
Approved
Approval ID
d63af5f0-c275-480b-89b5-6cf1ad55ab63
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 6, 2023
Manufacturers
FDA
Advagen Pharma Limited
DUNS: 051627256
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 Code72888-146
Application NumberANDA217324
Product Classification
M
Marketing Category
C73584
G
Generic Name
Baclofen
Product Specifications
Route of AdministrationINTRATHECAL
Effective DateMarch 6, 2023
FDA Product Classification
INGREDIENTS (3)
BACLOFENActive
Quantity: 1000 ug in 1 mL
Code: H789N3FKE8
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
Baclofen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72888-145
Application NumberANDA217324
Product Classification
M
Marketing Category
C73584
G
Generic Name
Baclofen
Product Specifications
Route of AdministrationINTRATHECAL
Effective DateMarch 6, 2023
FDA Product Classification
INGREDIENTS (3)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BACLOFENActive
Quantity: 500 ug in 1 mL
Code: H789N3FKE8
Classification: ACTIB
Baclofen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72888-147
Application NumberANDA217324
Product Classification
M
Marketing Category
C73584
G
Generic Name
Baclofen
Product Specifications
Route of AdministrationINTRATHECAL
Effective DateMarch 6, 2023
FDA Product Classification
INGREDIENTS (3)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BACLOFENActive
Quantity: 2000 ug in 1 mL
Code: H789N3FKE8
Classification: ACTIB