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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

NDC Product Code47781-607
Application NumberANDA091681
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 31, 2012
Generic NameDisulfiram

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

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Disulfiram - FDA Drug Approval Details