NDC Code(s) : 50090-1483-0, 50090-1483-1, 50090-1483-2, 50090-1483-4, 50090-0663-0, 50090-0663-1, 50090-0663-2
Packager : A-S Medication Solutions LLC

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:50090-1483(NDC:64376-630)
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)104.75 mg in 1 1
CORN(UNII: 0N8672707O)20.00 mg in 1 1
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)1.00 mg in 1 1
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)1.00 mg in 1 1
MAGNESIUM STEARATE(UNII: 70097M6I30)1.00 mg in 1 1
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)2.00 mg in 1 1
Product Characteristics
Color WHITE Score no score
Shape CAPSULE (CAPSULE-SHAPED) Size 5 mm
Flavor Imprint Code BP;630
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50090-1483-030 in 1 BOTTLE
2NDC:50090-1483-160 in 1 BOTTLE
3NDC:50090-1483-214 in 1 BOTTLE
4NDC:50090-1483-490 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090248 10/15/2010
Alprazolam Alprazolam TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-0663(NDC:64376-633)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALPRAZOLAM(UNII: YU55MQ3IZY)
(ALPRAZOLAM - UNII:YU55MQ3IZY)
ALPRAZOLAM2.00 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)208.00 mg in 1 1
CORN(UNII: 0N8672707O)40.00 mg in 1 1
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)2.00 mg in 1 1
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)2.00 mg in 1 1
MAGNESIUM STEARATE(UNII: 70097M6I30)2.00 mg in 1 1
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)4.00 mg in 1 1
Product Characteristics
Color WHITE Score no score
Shape ROUND (Circular) Size 5 mm
Flavor Imprint Code BP;633
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50090-0663-060 in 1 BOTTLE
2NDC:50090-0663-190 in 1 BOTTLE
3NDC:50090-0663-240 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090248 10/15/2010

PRINCIPAL DISPLAY PANEL

NDC 50090-1483-4

Packaged by:
A-S Medication Solutions
Libertyville, IL 60048


50090-1483-4.jpg

PRINCIPAL DISPLAY PANEL

NDC 50090-0663-1

Packaged by:
A-S Medication Solutions
Libertyville, IL 60048


50090-0663-1.jpg