NDC Code(s) : 0781-1061-01, 0781-1061-05, 0781-1061-10, 0781-1077-01, 0781-1077-05, 0781-1077-10, 0781-1079-01, 0781-1079-05, 0781-1079-10, 0781-1089-01, 0781-1089-05
Packager : Sandoz 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:0781-1061
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALPRAZOLAM(UNII: YU55MQ3IZY)
(ALPRAZOLAM - UNII:YU55MQ3IZY) 		ALPRAZOLAM.25 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
DOCUSATE SODIUM(UNII: F05Q2T2JA0)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM BENZOATE(UNII: OJ245FE5EU)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color WHITE (WHITE) Score 2 pieces
Shape OVAL (OVAL) Size 9 mm
Flavor Imprint Code GG256
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-1061-01100 in 1 BOTTLE Type 0: Not a Combination Product29/12/1995
2NDC:0781-1061-05500 in 1 BOTTLE Type 0: Not a Combination Product29/12/1995
3NDC:0781-1061-101000 in 1 BOTTLE Type 0: Not a Combination Product29/12/1995
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074112 12/29/1995 03/19/2027
AlprazolamAlprazolam TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-1077
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALPRAZOLAM(UNII: YU55MQ3IZY)
(ALPRAZOLAM - UNII:YU55MQ3IZY) 		ALPRAZOLAM.5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
DOCUSATE SODIUM(UNII: F05Q2T2JA0)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM BENZOATE(UNII: OJ245FE5EU)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color ORANGE (PEACH) Score 2 pieces
Shape OVAL (OVAL) Size 9 mm
Flavor Imprint Code GG257
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-1077-01100 in 1 BOTTLE Type 0: Not a Combination Product29/12/1995
2NDC:0781-1077-05500 in 1 BOTTLE Type 0: Not a Combination Product29/12/1995
3NDC:0781-1077-101000 in 1 BOTTLE Type 0: Not a Combination Product29/12/1995
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074112 12/29/1995 03/19/2027
AlprazolamAlprazolam TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-1079
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
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
DOCUSATE SODIUM(UNII: F05Q2T2JA0)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM BENZOATE(UNII: OJ245FE5EU)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color BLUE (BLUE) Score 2 pieces
Shape OVAL (OVAL) Size 9 mm
Flavor Imprint Code GG258
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-1079-01100 in 1 BOTTLE Type 0: Not a Combination Product29/12/1995
2NDC:0781-1079-05500 in 1 BOTTLE Type 0: Not a Combination Product29/12/1995
3NDC:0781-1079-101000 in 1 BOTTLE Type 0: Not a Combination Product29/12/1995
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074112 12/29/1995 03/19/2027
AlprazolamAlprazolam TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-1089
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
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
DOCUSATE SODIUM(UNII: F05Q2T2JA0)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM BENZOATE(UNII: OJ245FE5EU)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color WHITE (WHITE) Score 4 pieces
Shape RECTANGLE (RECTANBLE) Size 15 mm
Flavor Imprint Code GG249
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-1089-01100 in 1 BOTTLE Type 0: Not a Combination Product25/03/1998
2NDC:0781-1089-05500 in 1 BOTTLE Type 0: Not a Combination Product25/03/1998
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074909 03/25/1998 03/19/2027

LABELER - Sandoz Inc(005387188)

PRINCIPAL DISPLAY PANEL

NDC 0781-1061-01

Alprazolam

Tablets, USP CIV

0.25 mg

Rx only

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

100 Tablets

SANDOZ

0_25mg-100Tabs

PRINCIPAL DISPLAY PANEL

NDC 0781-1077-01

Alprazolam

Tablets, USP CIV

0.5 mg

Rx only

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

100 Tablets

SANDOZ

0_5mg-100Tabs

PRINCIPAL DISPLAY PANEL

NDC0781-1079-01

Alprazolam

Tablets, USP CIV

1 mg

Rx only

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

100 Tablets

SANDOZ

1mg-100Tabs

PRINCIPAL DISPLAY PANEL

NDC0781-1089-01

Alprazolam

Tablets, USP CIV

2 mg

Rx only

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

100 Tablets

SANDOZ

2mg-100Tabs