NDC Code(s) : 69238-1115-1, 69238-1115-5, 69238-1116-1, 69238-1116-5, 69238-1117-1, 69238-1117-5, 69238-1118-6, 69238-1118-1, 69238-1118-2, 69238-1118-5, 69238-1119-6, 69238-1119-5
Packager : Amneal Pharmaceuticals NY LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

busPIRone HClbuspirone hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1115
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUSPIRONE HYDROCHLORIDE(UNII: 207LT9J9OC)
(BUSPIRONE - UNII:TK65WKS8HL) 		BUSPIRONE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color white (white-to-off-white) Score 2 pieces
Shape ROUND Size 6 mm
Flavor Imprint Code AA;63
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69238-1115-1100 in 1 BOTTLE Type 0: Not a Combination Product24/05/2017
2NDC:69238-1115-5500 in 1 BOTTLE Type 0: Not a Combination Product24/05/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208829 05/24/2017
busPIRone HClbuspirone hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1116
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUSPIRONE HYDROCHLORIDE(UNII: 207LT9J9OC)
(BUSPIRONE - UNII:TK65WKS8HL) 		BUSPIRONE HYDROCHLORIDE7.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color white (white-to-off-white) Score 2 pieces
Shape OVAL Size 9 mm
Flavor Imprint Code AA;64
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69238-1116-1100 in 1 BOTTLE Type 0: Not a Combination Product24/05/2017
2NDC:69238-1116-5500 in 1 BOTTLE Type 0: Not a Combination Product24/05/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208829 05/24/2017
busPIRone HClbuspirone hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1117
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUSPIRONE HYDROCHLORIDE(UNII: 207LT9J9OC)
(BUSPIRONE - UNII:TK65WKS8HL) 		BUSPIRONE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color white (white-to-off-white) Score 2 pieces
Shape ROUND Size 8 mm
Flavor Imprint Code AA;65
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69238-1117-1100 in 1 BOTTLE Type 0: Not a Combination Product24/05/2017
2NDC:69238-1117-5500 in 1 BOTTLE Type 0: Not a Combination Product24/05/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208829 05/24/2017
busPIRone HClbuspirone hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1118
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUSPIRONE HYDROCHLORIDE(UNII: 207LT9J9OC)
(BUSPIRONE - UNII:TK65WKS8HL) 		BUSPIRONE HYDROCHLORIDE15 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color white (white-to-off-white) Score 3 pieces
Shape RECTANGLE Size 14 mm
Flavor Imprint Code A;0;5;5;5
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69238-1118-660 in 1 BOTTLE Type 0: Not a Combination Product24/05/2017
2NDC:69238-1118-1100 in 1 BOTTLE Type 0: Not a Combination Product24/05/2017
3NDC:69238-1118-2180 in 1 BOTTLE Type 0: Not a Combination Product24/05/2017
4NDC:69238-1118-5500 in 1 BOTTLE Type 0: Not a Combination Product24/05/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208829 05/24/2017
busPIRone HClbuspirone hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1119
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUSPIRONE HYDROCHLORIDE(UNII: 207LT9J9OC)
(BUSPIRONE - UNII:TK65WKS8HL) 		BUSPIRONE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color white (white-to-off-white) Score 3 pieces
Shape RECTANGLE Size 17 mm
Flavor Imprint Code AA;67;10;10;10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69238-1119-660 in 1 BOTTLE Type 0: Not a Combination Product24/05/2017
2NDC:69238-1119-5500 in 1 BOTTLE Type 0: Not a Combination Product24/05/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208829 05/24/2017

LABELER - Amneal Pharmaceuticals NY LLC(123797875)

Establishment
Name Address ID/FEI Business Operations
Amneal Pharmaceuticals Private Limited 650762060 manufacture(69238-1115, 69238-1116, 69238-1117, 69238-1118, 69238-1119), pack(69238-1115, 69238-1116, 69238-1117, 69238-1118, 69238-1119)

PRINCIPAL DISPLAY PANEL

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