buspirone hydrochloride

Product NDC
65841-842
11-digit product format
658410842
Labeler code
65841
Product ID
65841-842_0ea86a43-52f7-4fad-acda-a4625f4280a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA078888
Marketing category
ANDA
Marketing start
2023-03-21
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
7.5 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
65841-842-0165841084201100 TABLET in 1 BOTTLE (65841-842-01) 100 tablet2023-03-21NoNoHistorical
65841-842-0565841084205500 TABLET in 1 BOTTLE (65841-842-05) 500 tablet2023-03-21NoNoHistorical
65841-842-10658410842101000 TABLET in 1 BOTTLE (65841-842-10) 1000 tablet2023-03-21NoNoHistorical
65841-842-3065841084230100 BLISTER PACK in 1 CARTON (65841-842-30) / 10 TABLET in 1 BLISTER PACK100 blister pack2023-03-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Buspirone Hydrochloride TabletsZydus Lifesciences Limited2025-12-24HUMAN PRESCRIPTION DRUG LABEL9