Buspirone Hydrochloride

Product NDC
71610-826
11-digit product format
716100826
Labeler code
71610
Product ID
71610-826_3cb90647-ce37-159c-e063-6294a90a8772
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
2015-06-30
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
5 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
71610-826-307161008263030 TABLET in 1 BOTTLE (71610-826-30) 30 tablet2024-05-02NoNoHistorical
71610-826-537161008265360 TABLET in 1 BOTTLE (71610-826-53) 60 tablet2024-05-02NoNoHistorical
71610-826-607161008266090 TABLET in 1 BOTTLE (71610-826-60) 90 tablet2024-05-02NoNoHistorical
71610-826-8071610082680180 TABLET in 1 BOTTLE (71610-826-80) 180 tablet2025-08-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Buspirone Hydrochloride Tablets, USP (Patient Instruction Sheet Included)Aphena Pharma Solutions - Tennessee, LLC2025-08-19HUMAN PRESCRIPTION DRUG LABEL2