Buspirone Hydrochloride

Product NDC
71610-604
11-digit product format
716100604
Labeler code
71610
Product ID
71610-604_26f4d74c-2212-4bc2-ad7a-d9cb43a1ea34
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
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
71610-604-537161006045360 TABLET in 1 BOTTLE (71610-604-53) 60 tablet2021-10-19NoNoHistorical
71610-604-607161006046090 TABLET in 1 BOTTLE (71610-604-60) 90 tablet2021-10-19NoNoHistorical
71610-604-8071610060480180 TABLET in 1 BOTTLE (71610-604-80) 180 tablet2021-10-19NoNoHistorical
71610-604-9271610060492270 TABLET in 1 BOTTLE (71610-604-92) 270 tablet2021-10-19NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Buspirone Hydrochloride Tablets, USP (Patient Instruction Sheet Included)Aphena Pharma Solutions - Tennessee, LLC2021-10-28HUMAN PRESCRIPTION DRUG LABEL1