Lorazepam tablet

Ingredients and appearance - Product information

Lorazepam tablet- Lorazepam

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0615-8075
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Lorazepam ( UNII: O26FZP769L)( Lorazepam - UNII: O26FZP769L ) 0.5 mgin 1

Inactive Ingredients

Ingredient Name Code
Anhydrous lactose ( UNII: 3SY5LH9PMK)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Polacrilin potassium ( UNII: 0BZ5A00FQU)

Product Characteristics

Color WHITE Imprint Code EP;904
Score 1 Shape ROUND
Size 5 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0615-8075-39 30 in 1 BLISTER PACK 2016/12/22

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA078203 USA 2016/12/22

Lorazepam tablet- Lorazepam

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0615-8076
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Lorazepam ( UNII: O26FZP769L)( Lorazepam - UNII: O26FZP769L ) 1 mgin 1

Inactive Ingredients

Ingredient Name Code
Anhydrous lactose ( UNII: 3SY5LH9PMK)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Polacrilin potassium ( UNII: 0BZ5A00FQU)

Product Characteristics

Color WHITE Imprint Code EP;905;1
Score 2 Shape ROUND
Size 7 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0615-8076-39 30 in 1 BLISTER PACK 2016/12/15

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA078203 USA 2016/12/15

Lorazepam tablet- Lorazepam

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0615-8077
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Lorazepam ( UNII: O26FZP769L)( Lorazepam - UNII: O26FZP769L ) 2 mgin 1

Inactive Ingredients

Ingredient Name Code
Anhydrous lactose ( UNII: 3SY5LH9PMK)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Polacrilin potassium ( UNII: 0BZ5A00FQU)

Product Characteristics

Color WHITE Imprint Code EP;906;2
Score 2 Shape ROUND
Size 8 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0615-8077-39 30 in 1 BLISTER PACK 2016/12/14

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA078203 USA 2016/12/14

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs( 050052943)

Establishment

Name ID/FEI Business Operations
NCS HealthCare of KY, Inc dba Vangard Labs 050052943 REPACK( 0615-8075, 0615-8076, 0615-8077)