Baclofen
Baclofen Tablets USP Rx only
Approved
Approval ID
06bcfb08-2ada-f803-e063-6394a90a826b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2024
Manufacturers
FDA
Northwind Pharmaceuticals, LLC
DUNS: 036986393
Products 1
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 Code82868-013
Application NumberANDA072234
Product Classification
M
Marketing Category
C73584
G
Generic Name
Baclofen
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2024
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: O7TSZ97GEP
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: 10 mg in 1 1
Code: H789N3FKE8
Classification: ACTIB