Alprazolamextended release tablet, extended release

Ingredients and appearance - Product information

Alprazolamextended release tablet, extended release- Alprazolam

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0228-3083
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Alprazolam ( UNII: YU55MQ3IZY)( Alprazolam - UNII: YU55MQ3IZY ) 0.5 mgin 1

Inactive Ingredients

Ingredient Name Code
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Hypromellose, unspecified ( UNII: 3NXW29V3WO)
Magnesium stearate ( UNII: 70097M6I30)

Product Characteristics

Color WHITE (to off white) Imprint Code R;83
Score 1 Shape ROUND
Size 10 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0228-3083-06 60 in 1 BOTTLE 2007/03/12

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA078056 USA 2007/03/12

Alprazolamextended release tablet, extended release- Alprazolam

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0228-3084
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Alprazolam ( UNII: YU55MQ3IZY)( Alprazolam - UNII: YU55MQ3IZY ) 1 mgin 1

Inactive Ingredients

Ingredient Name Code
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Hypromellose, unspecified ( UNII: 3NXW29V3WO)
Magnesium stearate ( UNII: 70097M6I30)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)

Product Characteristics

Color YELLOW Imprint Code R;84
Score 1 Shape ROUND
Size 10 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0228-3084-06 60 in 1 BOTTLE 2007/03/12

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA078056 USA 2007/03/12

Alprazolamextended release tablet, extended release- Alprazolam

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0228-3087
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Alprazolam ( UNII: YU55MQ3IZY)( Alprazolam - UNII: YU55MQ3IZY ) 2 mgin 1

Inactive Ingredients

Ingredient Name Code
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Hypromellose, unspecified ( UNII: 3NXW29V3WO)
Magnesium stearate ( UNII: 70097M6I30)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)

Product Characteristics

Color PINK (PEACH) Imprint Code R;87
Score 1 Shape ROUND
Size 10 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0228-3087-06 60 in 1 BOTTLE 2007/03/12

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA078056 USA 2007/03/12

Alprazolamextended release tablet, extended release- Alprazolam

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0228-3086
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Alprazolam ( UNII: YU55MQ3IZY)( Alprazolam - UNII: YU55MQ3IZY ) 3 mgin 1

Inactive Ingredients

Ingredient Name Code
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Hypromellose, unspecified ( UNII: 3NXW29V3WO)
Magnesium stearate ( UNII: 70097M6I30)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Fd&c blue no. 2 ( UNII: L06K8R7DQK)
Indigotindisulfonate sodium ( UNII: D3741U8K7L)

Product Characteristics

Color GREEN (light) Imprint Code R;86
Score 1 Shape ROUND
Size 10 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0228-3086-06 60 in 1 BOTTLE 2007/03/12

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA078056 USA 2007/03/12

Labeler - Actavis Pharma, Inc.( 119723554)