Clonazepam tablet

Ingredients and appearance - Product information

Clonazepam tablet- Clonazepam

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 50090-0686
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Clonazepam ( UNII: 5PE9FDE8GB)( Clonazepam - UNII: 5PE9FDE8GB ) 1 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Croscarmellose sodium ( UNII: M28OL1HH48)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)

Product Characteristics

Color BLUE (light blue) Imprint Code 2531;V
Score 1 Shape ROUND
Size 8 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 50090-0686-0 60 in 1 BOTTLE, PLASTIC 2014/11/28
2 NDC: 50090-0686-1 30 in 1 BOTTLE, PLASTIC 2014/11/28
3 NDC: 50090-0686-2 90 in 1 BOTTLE, PLASTIC 2014/11/28

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA077856 USA 2014/11/28

Clonazepam tablet- Clonazepam

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 50090-0721
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Clonazepam ( UNII: 5PE9FDE8GB)( Clonazepam - UNII: 5PE9FDE8GB ) 0.5 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Croscarmellose sodium ( UNII: M28OL1HH48)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)

Product Characteristics

Color YELLOW (light yellow) Imprint Code 2530;V
Score 2 Shape ROUND
Size 8 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 50090-0721-0 30 in 1 BOTTLE, PLASTIC 2014/11/28
2 NDC: 50090-0721-2 90 in 1 BOTTLE, PLASTIC 2014/11/28
3 NDC: 50090-0721-1 60 in 1 BOTTLE 2014/11/14

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA077856 USA 2014/11/14

Labeler - A-S Medication Solutions( 830016429)

Establishment

Name ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL( 50090-0721, 50090-0686), REPACK( 50090-0686, 50090-0721)

Clonazepam

Clonazepam

Events reported by at least 1% of patients treated with clonazepam and for which the incidence was greater than that for placebo.
Indicates that the p-value for the dose-trend test (Cochran-Mantel-Haenszel) for adverse event incidence was 0.10.
Denominators for events in gender-specific systems are: n=240 (clonazepam), 102 (placebo) for male, and 334 (clonazepam), 192 (placebo) for female.
Treatment-emergent events for which the incidence in the clonazepam patients was 5% and at least twice that in the placebo patients.