Disulfiram
Disulfiram Tablets, USP IN ALCOHOLISM
Approved
Approval ID
40f5497f-fe84-43b2-8ff4-32d59edf3917
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2022
Manufacturers
FDA
Sigmapharm Laboratories, LLC
DUNS: 556234636
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Disulfiram
PRODUCT DETAILS
NDC Product Code42794-029
Application NumberANDA091619
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 11, 2022
Generic NameDisulfiram
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DISULFIRAMActive
Quantity: 500 mg in 1 1
Code: TR3MLJ1UAI
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
Disulfiram
PRODUCT DETAILS
NDC Product Code42794-028
Application NumberANDA091619
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 11, 2022
Generic NameDisulfiram
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DISULFIRAMActive
Quantity: 250 mg in 1 1
Code: TR3MLJ1UAI
Classification: ACTIB