Buspirone hydrochloride

Product NDC
71610-975
11-digit product format
716100975
Labeler code
71610
Product ID
71610-975_45c63c90-30a3-54ff-e063-6394a90af15f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA202087
Marketing category
ANDA
Marketing start
2025-09-18
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
15 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
71610-975-607161009756090 TABLET in 1 BOTTLE (71610-975-60) 90 tablet2025-12-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
BUSPIRONE HYDROCHLORIDE TABLETS, USP (Patient Instruction Sheet Included) Rx onlyAphena Pharma Solutions - Tennessee, LLC2025-12-12HUMAN PRESCRIPTION DRUG LABEL1