NDC Code(s) : 0228-2027-10, 0228-2027-50, 0228-2027-96, 0228-2029-10, 0228-2029-50, 0228-2029-96, 0228-2031-10, 0228-2031-50, 0228-2031-96, 0228-2039-10
Packager : Actavis Pharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AlprazolamAlprazolam TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-2027
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
DOCUSATE SODIUM(UNII: F05Q2T2JA0)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM BENZOATE(UNII: OJ245FE5EU)
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 7 mm
Flavor Imprint Code R;027
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0228-2027-10100 in 1 BOTTLE Type 0: Not a Combination Product10/01/1993
2NDC:0228-2027-50500 in 1 BOTTLE Type 0: Not a Combination Product10/01/1993
3NDC:0228-2027-961000 in 1 BOTTLE Type 0: Not a Combination Product10/01/1993
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074342 10/01/1993
AlprazolamAlprazolam TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-2029
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
DOCUSATE SODIUM(UNII: F05Q2T2JA0)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM BENZOATE(UNII: OJ245FE5EU)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Product Characteristics
Color orange (PEACH) Score 2 pieces
Shape ROUND Size 7 mm
Flavor Imprint Code R;029
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0228-2029-10100 in 1 BOTTLE Type 0: Not a Combination Product10/01/1993
2NDC:0228-2029-50500 in 1 BOTTLE Type 0: Not a Combination Product10/01/1993
3NDC:0228-2029-961000 in 1 BOTTLE Type 0: Not a Combination Product10/01/1993
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074342 10/01/1993
AlprazolamAlprazolam TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-2031
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
DOCUSATE SODIUM(UNII: F05Q2T2JA0)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM BENZOATE(UNII: OJ245FE5EU)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color blue Score 2 pieces
Shape ROUND Size 7 mm
Flavor Imprint Code R;031
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0228-2031-10100 in 1 BOTTLE Type 0: Not a Combination Product10/01/1993
2NDC:0228-2031-50500 in 1 BOTTLE Type 0: Not a Combination Product10/01/1993
3NDC:0228-2031-961000 in 1 BOTTLE Type 0: Not a Combination Product10/01/1993
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074342 10/01/1993
AlprazolamAlprazolam TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-2039
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
DOCUSATE SODIUM(UNII: F05Q2T2JA0)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM BENZOATE(UNII: OJ245FE5EU)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
Product Characteristics
Color yellow Score 4 pieces
Shape RECTANGLE Size 15 mm
Flavor Imprint Code R;039
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0228-2039-10100 in 1 BOTTLE Type 0: Not a Combination Product10/01/1993
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074342 10/01/1993

LABELER - Actavis Pharma, Inc.(119723554)

PRINCIPAL DISPLAY PANEL

NDC 0228-2027-10

Alprazolam Tablets, USP CIV

0.25 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

100 Tablets

Rx Only

1

PRINCIPAL DISPLAY PANEL

NDC 0228-2029-10

Alprazolam Tablets, USP CIV

0.5 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

100 Tablets

Rx Only

1

PRINCIPAL DISPLAY PANEL

NDC 0228-2031-10

Alprazolam Tablets, USP CIV

1 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

100 Tablets

Rx Only

1

PRINCIPAL DISPLAY PANEL

NDC 0228-2039-10

Alprazolam Tablets, USP CIV

2 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

100 Tablets

Rx Only

1