Buspirone Hydrochloride

Product NDC
68071-3834
11-digit product format
680713834
Labeler code
68071
Product ID
68071-3834_335107d2-e2ba-835d-e063-6394a90a9142
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA210907
Marketing category
ANDA
Marketing start
2023-10-17
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
68071-3834-36807138340330 TABLET in 1 BOTTLE, PLASTIC (68071-3834-3) 30 tablet2025-04-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Buspirone Hydrochloride Tablets, USP Rx OnlyNuCare Pharmaceuticals, Inc.2025-04-21HUMAN PRESCRIPTION DRUG LABEL1