Buspirone Hydrochloride

Product NDC
71610-953
11-digit product format
716100953
Labeler code
71610
Product ID
71610-953_40d5814d-4005-ebb0-e063-6294a90a8264
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075388
Marketing category
ANDA
Marketing start
2020-07-27
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
71610-953-537161009535360 TABLET in 1 BOTTLE (71610-953-53) 60 tablet2025-10-10NoNoHistorical
71610-953-607161009536090 TABLET in 1 BOTTLE (71610-953-60) 90 tablet2025-10-10NoNoHistorical
71610-953-7071610095370120 TABLET in 1 BOTTLE (71610-953-70) 120 tablet2025-10-10NoNoHistorical
71610-953-8071610095380180 TABLET in 1 BOTTLE (71610-953-80) 180 tablet2025-10-10NoNoHistorical
71610-953-9271610095392270 TABLET in 1 BOTTLE (71610-953-92) 270 tablet2025-10-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Buspirone Hydrochloride - Aphena Pharma Solutions - Tennessee, LLCAphena Pharma Solutions - Tennessee, LLC2025-10-10HUMAN PRESCRIPTION DRUG LABEL1