Buspirone Hydrochloride (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — 15 mg

NDC 60429-293-60

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.

Marketed/ Packaged by:
GSMS, Inc. Camarillo, CA 93012 USA

GSMS.us

RM1165D7

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BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-291(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
MICROCRYSTALLINE CELLULOSE
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:60429-291-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:60429-291-05 500 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076008 02/09/2015 11/23/2015
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-292(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
MICROCRYSTALLINE CELLULOSE
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:60429-292-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:60429-292-05 500 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076008 02/09/2015 03/01/2021
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-293(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
MICROCRYSTALLINE CELLULOSE
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:60429-293-60 60 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:60429-293-05 500 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076008 02/09/2015 02/01/2021
Labeler — Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply, Inc. 603184490 repack (60429-291), repack (60429-292), repack (60429-293), relabel (60429-291), relabel (60429-292), relabel (60429-293)

Revised: 03/2020 Golden State Medical Supply, Inc.

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