Buspirone Hydrochloride

Product NDC
71610-596
11-digit product format
716100596
Labeler code
71610
Product ID
71610-596_828fb9f6-df15-4aaf-9562-c17fe0e32197
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA202330
Marketing category
ANDA
Marketing start
2014-08-25
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
207LT9J9OCBUSPIRONE HYDROCHLORIDE33386-08-2BUSPIRONE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-596-537161005965360 TABLET in 1 BOTTLE (71610-596-53) 60 tablet2021-09-09NoNoHistorical
71610-596-607161005966090 TABLET in 1 BOTTLE (71610-596-60) 90 tablet2021-09-09NoNoHistorical
71610-596-7071610059670120 TABLET in 1 BOTTLE (71610-596-70) 120 tablet2021-09-09NoNoHistorical
71610-596-8071610059680180 TABLET in 1 BOTTLE (71610-596-80) 180 tablet2021-09-09NoNoHistorical
71610-596-9271610059692270 TABLET in 1 BOTTLE (71610-596-92) 270 tablet2021-09-09NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Buspirone Hydrochloride Tablets, USP (Patient Instruction Sheet Included)Aphena Pharma Solutions - Tennessee, LLC2021-09-29HUMAN PRESCRIPTION DRUG LABEL1