NDC Code(s) : 0603-3433-19, 0603-3433-21, 0603-3433-28, 0603-3432-19, 0603-3432-21, 0603-3432-28
Packager : Qualitest Pharmaceuticals

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Disulfiramdisulfiram TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0603-3433
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DISULFIRAM(UNII: TR3MLJ1UAI)
(DISULFIRAM - UNII:TR3MLJ1UAI) 		DISULFIRAM250 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLOXAMER 188(UNII: LQA7B6G8JG)
Product Characteristics
Color WHITE (off-white) Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code 3431;V
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0603-3433-1950 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/12/2012
2NDC:0603-3433-21100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/12/2012
3NDC:0603-3433-28500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/12/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091563 12/31/2012 01/31/2016
Disulfiramdisulfiram TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0603-3432
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DISULFIRAM(UNII: TR3MLJ1UAI)
(DISULFIRAM - UNII:TR3MLJ1UAI) 		DISULFIRAM500 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLOXAMER 188(UNII: LQA7B6G8JG)
Product Characteristics
Color WHITE (off-white) Score 2 pieces
Shape ROUND Size 13 mm
Flavor Imprint Code 3432;V
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0603-3432-1950 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/12/2012
2NDC:0603-3432-21100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/12/2012
3NDC:0603-3432-28500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/12/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091563 12/31/2012 01/31/2016

PRINCIPAL DISPLAY PANEL

This is an image of the label for Disulfiram Tablets USP 250 mg 100 count. 

PRINCIPAL DISPLAY PANEL

This is an image of the label for Disulfiram Tablets USP 500 mg 100 count.