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

PRINCIPAL DISPLAY PANEL — 0.25 mg

Image of the label for Alprazolam Tablets, USP 0.25 mg 100 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.5 mg

Image of the label for Alprazolam Tablets, USP 0.5 mg 100 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 1 mg

Image of the label for Alprazolam Tablets, USP 1 mg 100 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 2 mg

Image of the label for Alprazolam Tablets, USP 2 mg 100 Tablets
(click image for full-size original)
ALPRAZOLAM alprazolam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-502(NDC:67253-900)
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
DOCUSATE SODIUM
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
SODIUM BENZOATE
STARCH, CORN
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 9mm
Flavor Imprint Code S;900
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-502-90 90 TABLET in 1 BOTTLE None
2 NDC:60429-502-01 100 TABLET in 1 BOTTLE None
3 NDC:60429-502-10 1000 TABLET in 1 BOTTLE None
4 NDC:60429-502-05 500 TABLET in 1 BOTTLE None
5 NDC:60429-502-30 30 TABLET in 1 BOTTLE None
6 NDC:60429-502-60 60 TABLET in 1 BOTTLE None
7 NDC:60429-502-12 120 TABLET in 1 BOTTLE None
8 NDC:60429-502-15 150 TABLET in 1 BOTTLE None
9 NDC:60429-502-18 180 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074174 03/28/2007 10/10/2017
ALPRAZOLAM alprazolam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-503(NDC:67253-901)
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
CROSPOVIDONE
DOCUSATE SODIUM
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
SODIUM BENZOATE
STARCH, CORN
D&C YELLOW NO. 10
Product Characteristics
Color yellow Score 2 pieces
Shape OVAL Size 9mm
Flavor Imprint Code S;901
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-503-01 100 TABLET in 1 BOTTLE None
2 NDC:60429-503-10 1000 TABLET in 1 BOTTLE None
3 NDC:60429-503-30 30 TABLET in 1 BOTTLE None
4 NDC:60429-503-45 45 TABLET in 1 BOTTLE None
5 NDC:60429-503-60 60 TABLET in 1 BOTTLE None
6 NDC:60429-503-90 90 TABLET in 1 BOTTLE None
7 NDC:60429-503-18 180 TABLET in 1 BOTTLE None
8 NDC:60429-503-12 120 TABLET in 1 BOTTLE None
9 NDC:60429-503-15 150 TABLET in 1 BOTTLE None
10 NDC:60429-503-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074174 03/28/2007 10/10/2017
ALPRAZOLAM alprazolam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-504(NDC:67253-902)
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
CROSPOVIDONE
DOCUSATE SODIUM
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
SODIUM BENZOATE
STARCH, CORN
FD&C BLUE NO. 2
D&C YELLOW NO. 10
Product Characteristics
Color green Score 2 pieces
Shape OVAL Size 9mm
Flavor Imprint Code S;902
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-504-01 100 TABLET in 1 BOTTLE None
2 NDC:60429-504-10 1000 TABLET in 1 BOTTLE None
3 NDC:60429-504-05 500 TABLET in 1 BOTTLE None
4 NDC:60429-504-30 30 TABLET in 1 BOTTLE None
5 NDC:60429-504-60 60 TABLET in 1 BOTTLE None
6 NDC:60429-504-90 90 TABLET in 1 BOTTLE None
7 NDC:60429-504-12 120 TABLET in 1 BOTTLE None
8 NDC:60429-504-15 150 TABLET in 1 BOTTLE None
9 NDC:60429-504-18 180 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074174 03/28/2007
ALPRAZOLAM alprazolam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-505(NDC:67253-903)
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
CROSPOVIDONE
DOCUSATE SODIUM
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
SODIUM BENZOATE
STARCH, CORN
FD&C BLUE NO. 2
D&C YELLOW NO. 10
Product Characteristics
Color green Score 3 pieces
Shape RECTANGLE Size 15mm
Flavor Imprint Code S;90;3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-505-01 100 TABLET in 1 BOTTLE None
2 NDC:60429-505-05 500 TABLET in 1 BOTTLE None
3 NDC:60429-505-60 60 TABLET in 1 BOTTLE None
4 NDC:60429-505-15 150 TABLET in 1 BOTTLE None
5 NDC:60429-505-18 180 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074174 10/19/1993
Labeler — Golden State Medical Supply Inc (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply Inc 603184490 relabel (60429-502), repack (60429-502), relabel (60429-503), repack (60429-503), relabel (60429-504), repack (60429-504), relabel (60429-505), repack (60429-505)

Revised: 10/2019 Golden State Medical Supply Inc

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