Disulfiram
Disulfiram Tablets, USPIN ALCOHOLISM Rx only
Approved
Approval ID
b90f8ff4-4fb3-46ab-8149-cb55f24a4044
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 13, 2023
Manufacturers
FDA
Alvogen Inc.
DUNS: 008057330
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 Code47781-607
Application NumberANDA091681
Product Classification
M
Marketing Category
C73584
G
Generic Name
Disulfiram
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2012
FDA Product Classification
INGREDIENTS (7)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
DISULFIRAMActive
Quantity: 250 mg in 1 1
Code: TR3MLJ1UAI
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT