Disulfiram
Disulfiram Tablets, USPIN ALCOHOLISM Rx only
Approved
Approval ID
bd09ba63-7eef-4740-b5e9-383887024f1f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 7, 2025
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Disulfiram
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-5466
Application NumberANDA091681
Product Classification
M
Marketing Category
C73584
G
Generic Name
Disulfiram
Product Specifications
Route of AdministrationORAL
Effective DateApril 7, 2025
FDA Product Classification
INGREDIENTS (7)
DISULFIRAMActive
Quantity: 250 mg in 1 1
Code: TR3MLJ1UAI
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT