Buspirone Hydrochloride (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — 10 mg

NDC 0378-1150-01

busPIRone
Hydrochloride
Tablets, USP
10 mg

Rx only 100 Tablets

Each tablet contains: Buspirone
hydrochloride, USP 10 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Usual Dosage: See accompanying
prescribing information.

Mylan Pharmaceuticals Inc. Morgantown, WV 26505

Mylan.com

RM1150A7

PRINCIPAL DISPLAY PANEL — 15 mg

NDC 0378-1165-91

busPIRone
Hydrochloride
Tablets, USP
15 mg

PHARMACIST: Dispense the accompanying
Patient Instruction Sheet to each patient.

Rx only 60 Tablets

Each tablet contains: Buspirone
hydrochloride, USP 15 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Usual Dosage: See accompanying
prescribing information.

Mylan Pharmaceuticals Inc. Morgantown, WV 26505

Mylan.com

RM1165D7

PRINCIPAL DISPLAY PANEL — 30 mg

NDC 0378-1175-91

busPIRone
Hydrochloride
Tablets, USP
30 mg

PHARMACIST: Dispense the accompanying
Patient InstructionSheet to each patient.

Rx only 60 Tablets

Each tablet contains: Buspirone
hydrochloride, USP 30 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Usual Dosage: See accompanying
prescribing information.

Mylan Pharmaceuticals Inc. Morgantown, WV 26505

Mylan.com

RM1175D7

BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-1140 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUSPIRONE HYDROCHLORIDE (BUSPIRONE) BUSPIRONE HYDROCHLORIDE 5 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE SILICON DIOXIDE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color WHITE Score 2 pieces Shape OVAL Size 9mm Flavor Imprint Code M;B1 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0378-1140-01 100 TABLET in 1 BOTTLE, PLASTIC None 2 NDC:0378-1140-05 500 TABLET in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076008 03/01/2002

BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-1145 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUSPIRONE HYDROCHLORIDE (BUSPIRONE) BUSPIRONE HYDROCHLORIDE 7.5 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE SILICON DIOXIDE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color WHITE (white to off-white) Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code M;B7 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0378-1145-01 100 TABLET in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076008 07/08/2013

BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-1150 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUSPIRONE HYDROCHLORIDE (BUSPIRONE) BUSPIRONE HYDROCHLORIDE 10 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE SILICON DIOXIDE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color WHITE Score 2 pieces Shape OVAL Size 12mm Flavor Imprint Code M;B2 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0378-1150-01 100 TABLET in 1 BOTTLE, PLASTIC None 2 NDC:0378-1150-05 500 TABLET in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076008 03/01/2002

BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-1165 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUSPIRONE HYDROCHLORIDE (BUSPIRONE) BUSPIRONE HYDROCHLORIDE 15 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE SILICON DIOXIDE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color WHITE Score 3 pieces Shape OVAL (capsule-shaped) Size 18mm Flavor Imprint Code M;B3;5;5;5 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0378-1165-91 60 TABLET in 1 BOTTLE, PLASTIC None 2 NDC:0378-1165-80 180 TABLET in 1 BOTTLE, PLASTIC None 3 NDC:0378-1165-05 500 TABLET in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076008 03/28/2001

BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-1175 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUSPIRONE HYDROCHLORIDE (BUSPIRONE) BUSPIRONE HYDROCHLORIDE 30 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE SILICON DIOXIDE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color WHITE Score 3 pieces Shape OVAL (capsule-shaped) Size 18mm Flavor Imprint Code M;B4;10;10;10 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0378-1175-91 60 TABLET in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076008 06/28/2001

Labeler — Mylan Pharmaceuticals Inc. (059295980)

Revised: 12/2016 Mylan Pharmaceuticals Inc.