BusPIRone HCl (Page 5 of 5)

Storage

Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

buspirone hydrochloride

Label ImageLabel Image
BUSPIRONE HCL buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-4657(NDC:69238-1118)
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
SILICON DIOXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white (white-to-off-white) Score 3 pieces
Shape RECTANGLE Size 14mm
Flavor Imprint Code A;0;5;5;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-4657-3 90 TABLET in 1 BOTTLE None
2 NDC:50090-4657-1 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208829 05/24/2017
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-4657), REPACK (50090-4657)

Revised: 06/2021 A-S Medication Solutions

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