Antabuse
ANTABUSE®(Disulfiram Tablets USP)IN ALCOHOLISM
Approved
Approval ID
12850de3-c97c-42c1-b8d3-55dc6fd05750
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 18, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-5034
Application NumberANDA088482
Product Classification
M
Marketing Category
C73584
G
Generic Name
Disulfiram
Product Specifications
Route of AdministrationORAL
Effective DateApril 18, 2012
FDA Product Classification
INGREDIENTS (7)
DISULFIRAMActive
Quantity: 250 mg in 1 1
Code: TR3MLJ1UAI
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT