Buspirone Hydrochloride

Product NDC
71610-404
11-digit product format
716100404
Labeler code
71610
Product ID
71610-404_a93360e6-43f6-4652-a7ef-07087a718258
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA208972
Marketing category
ANDA
Marketing start
2019-04-17
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
71610-404-607161004046090 TABLET in 1 BOTTLE (71610-404-60) 90 tablet2020-03-09NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Buspirone Hydrochloride Tablets, USP Rx Only (Patient Instruction Sheet Included)Aphena Pharma Solutions - Tennessee, LLC2020-04-09HUMAN PRESCRIPTION DRUG LABEL1