NDC Code(s) : 47335-603-83, 47335-603-88, 47335-603-08, 47335-603-13, 47335-603-18, 47335-604-83, 47335-604-88, 47335-604-08, 47335-604-13, 47335-604-18, 47335-605-83, 47335-605-88, 47335-605-08, 47335-605-13, 47335-605-18, 47335-606-83, 47335-606-88, 47335-606-08, 47335-606-13, 47335-606-18
Packager : Sun Pharma Global FZE

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Alprazolam Alprazolam TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-603
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALPRAZOLAM(UNII: YU55MQ3IZY)
(ALPRAZOLAM - UNII:YU55MQ3IZY) 		ALPRAZOLAM0.25 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POVIDONE K30(UNII: U725QWY32X)
DOCUSATE SODIUM(UNII: F05Q2T2JA0)
SODIUM BENZOATE(UNII: OJ245FE5EU)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 9 mm
Flavor Imprint Code 603
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:47335-603-8330 in 1 BOTTLE Type 0: Not a Combination Product18/06/2010
2NDC:47335-603-88100 in 1 BOTTLE Type 0: Not a Combination Product18/06/2010
3NDC:47335-603-08100 in 1 BOTTLE Type 0: Not a Combination Product18/06/2010
4NDC:47335-603-13500 in 1 BOTTLE Type 0: Not a Combination Product18/06/2010
5NDC:47335-603-181000 in 1 BOTTLE Type 0: Not a Combination Product18/06/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090082 06/18/2010 11/30/2016
Alprazolam Alprazolam TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-604
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALPRAZOLAM(UNII: YU55MQ3IZY)
(ALPRAZOLAM - UNII:YU55MQ3IZY) 		ALPRAZOLAM0.5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POVIDONE K30(UNII: U725QWY32X)
DOCUSATE SODIUM(UNII: F05Q2T2JA0)
SODIUM BENZOATE(UNII: OJ245FE5EU)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Product Characteristics
Color ORANGE (peach) Score 2 pieces
Shape OVAL Size 9 mm
Flavor Imprint Code 604
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:47335-604-8330 in 1 BOTTLE Type 0: Not a Combination Product18/06/2010
2NDC:47335-604-88100 in 1 BOTTLE Type 0: Not a Combination Product18/06/2010
3NDC:47335-604-08100 in 1 BOTTLE Type 0: Not a Combination Product18/06/2010
4NDC:47335-604-13500 in 1 BOTTLE Type 0: Not a Combination Product18/06/2010
5NDC:47335-604-181000 in 1 BOTTLE Type 0: Not a Combination Product18/06/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090082 06/18/2010 11/30/2016
Alprazolam Alprazolam TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-605
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALPRAZOLAM(UNII: YU55MQ3IZY)
(ALPRAZOLAM - UNII:YU55MQ3IZY) 		ALPRAZOLAM1 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POVIDONE K30(UNII: U725QWY32X)
DOCUSATE SODIUM(UNII: F05Q2T2JA0)
SODIUM BENZOATE(UNII: OJ245FE5EU)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color BLUE Score 2 pieces
Shape OVAL Size 9 mm
Flavor Imprint Code 605
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:47335-605-8330 in 1 BOTTLE Type 0: Not a Combination Product18/06/2010
2NDC:47335-605-88100 in 1 BOTTLE Type 0: Not a Combination Product18/06/2010
3NDC:47335-605-08100 in 1 BOTTLE Type 0: Not a Combination Product18/06/2010
4NDC:47335-605-13500 in 1 BOTTLE Type 0: Not a Combination Product18/06/2010
5NDC:47335-605-181000 in 1 BOTTLE Type 0: Not a Combination Product18/06/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090082 06/18/2010 11/30/2016
Alprazolam Alprazolam TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-606
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALPRAZOLAM(UNII: YU55MQ3IZY)
(ALPRAZOLAM - UNII:YU55MQ3IZY) 		ALPRAZOLAM2 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POVIDONE K30(UNII: U725QWY32X)
DOCUSATE SODIUM(UNII: F05Q2T2JA0)
SODIUM BENZOATE(UNII: OJ245FE5EU)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE Score 4 pieces
Shape CAPSULE (oblong) Size 15 mm
Flavor Imprint Code 1;1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:47335-606-8330 in 1 BOTTLE Type 0: Not a Combination Product18/06/2010
2NDC:47335-606-88100 in 1 BOTTLE Type 0: Not a Combination Product18/06/2010
3NDC:47335-606-08100 in 1 BOTTLE Type 0: Not a Combination Product18/06/2010
4NDC:47335-606-13500 in 1 BOTTLE Type 0: Not a Combination Product18/06/2010
5NDC:47335-606-181000 in 1 BOTTLE Type 0: Not a Combination Product18/06/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090082 06/18/2010 11/30/2016

PRINCIPAL DISPLAY PANEL


NDC 47335-603-88
Alprazolam Tablets, USP CIV
0.25 mg
Rx only
100 Tablets
SUN PHARMA


alprazolam-0.25mg

PRINCIPAL DISPLAY PANEL



NDC 47335-604-88
Alprazolam Tablets, USP CIV
0.5 mg
Rx only
100 Tablets
SUN PHARMA


alprazolam-0.5mg

PRINCIPAL DISPLAY PANEL



NDC 47335-605-88
Alprazolam Tablets, USP CIV
1 mg
Rx only
100 Tablets
SUN PHARMA


alprazolam-1mg

PRINCIPAL DISPLAY PANEL



NDC 47335-606-88
Alprazolam Tablets, USP CIV
2 mg
Rx only
100 Tablets
SUN PHARMA


alprazolam-2mg