Alprazolam: Package Insert and Label Information (Page 5 of 5)

PRINCIPAL DISPLAY PANEL

NDC 0228-4024 -11
Alprazolam Orally Disintegrating Tablets, USP CIV
1 mg
100 Tablets
Rx Only
ActavisPHARMACIST: Dispense the accompanying Medication Guide to each patient.

1mglabel
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0228-4025 -11
Alprazolam Orally Disintegrating Tablets, USP CIV
2 mg
100 Tablets
Rx Only
Actavis PHARMACIST: Dispense the accompanying Medication Guide to each patient.

2mglabel
(click image for full-size original)

ALPRAZOLAM alprazolam tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-4019
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALPRAZOLAM (ALPRAZOLAM) ALPRAZOLAM 0.25 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (15 MPA.S AT 5%)
MAGNESIUM STEARATE
MANNITOL
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
MICROCRYSTALLINE CELLULOSE
POLYSORBATE 80
SODIUM LAURYL SULFATE
SUCRALOSE
STARCH, CORN
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape ROUND Size 6mm
Flavor ORANGE (natural and artificial) Imprint Code 019
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0228-4019-11 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078561 03/17/2010
ALPRAZOLAM alprazolam tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-4022
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALPRAZOLAM (ALPRAZOLAM) ALPRAZOLAM 0.5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CROSPOVIDONE (15 MPA.S AT 5%)
MAGNESIUM STEARATE
MANNITOL
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
MICROCRYSTALLINE CELLULOSE
POLYSORBATE 80
SODIUM LAURYL SULFATE
SUCRALOSE
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape ROUND Size 8mm
Flavor ORANGE (natural and artificial) Imprint Code 022
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0228-4022-11 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078561 03/17/2010
ALPRAZOLAM alprazolam tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-4024
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALPRAZOLAM (ALPRAZOLAM) ALPRAZOLAM 1 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CROSPOVIDONE (15 MPA.S AT 5%)
MAGNESIUM STEARATE
MANNITOL
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
MICROCRYSTALLINE CELLULOSE
POLYSORBATE 80
SODIUM LAURYL SULFATE
SUCRALOSE
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 8mm
Flavor ORANGE (natural and artificial) Imprint Code 024
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0228-4024-11 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078561 03/17/2010
ALPRAZOLAM alprazolam tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-4025
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALPRAZOLAM (ALPRAZOLAM) ALPRAZOLAM 2 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CROSPOVIDONE (15 MPA.S AT 5%)
MAGNESIUM STEARATE
MANNITOL
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
MICROCRYSTALLINE CELLULOSE
POLYSORBATE 80
SODIUM LAURYL SULFATE
SUCRALOSE
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 10mm
Flavor ORANGE (natural and artificial) Imprint Code 025
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0228-4025-11 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078561 03/17/2010
Labeler — Actavis Pharma, Inc. (119723554)

Revised: 11/2019 Actavis Pharma, Inc.

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