Buspirone Hydrochloride

Product NDC
71610-608
11-digit product format
716100608
Labeler code
71610
Product ID
71610-608_2d05f5d2-27b7-413b-bd6c-43d3e047e38a
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
2017-02-17
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
7.5 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
71610-608-607161006086090 TABLET in 1 BOTTLE (71610-608-60) 90 tablet2021-10-26NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Buspirone Hydrochloride Tablets, USP (Patient Instruction Sheet Included)Aphena Pharma Solutions - Tennessee, LLC2021-11-08HUMAN PRESCRIPTION DRUG LABEL1