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Disulfiram

Disulfiram Tablets, USP

Approved
Approval ID

35f34124-7300-4b96-911f-d9f03016ea14

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 30, 2013

Manufacturers
FDA

Carilion Materials Management

DUNS: 079239644

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 Code68151-2694
Application NumberANDA091619
Product Classification
M
Marketing Category
C73584
G
Generic Name
Disulfiram
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2013
FDA Product Classification

INGREDIENTS (7)

DISULFIRAMActive
Quantity: 250 mg in 1 1
Code: TR3MLJ1UAI
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT

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Disulfiram - FDA Drug Approval Details