Buspirone Hydrochloride

Product NDC
82804-104
11-digit product format
828040104
Labeler code
82804
Product ID
82804-104_79b241f2-152a-4aba-9f0a-d3dfb1edef3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA210907
Marketing category
ANDA
Marketing start
2019-11-14
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
10 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
82804-104-308280401043030 TABLET in 1 BOTTLE, PLASTIC (82804-104-30) 30 tablet2024-05-13NoNoHistorical
82804-104-608280401046060 TABLET in 1 BOTTLE, PLASTIC (82804-104-60) 60 tablet2025-08-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Buspirone Hydrochloride Tablets, USP Rx OnlyProficient Rx LP2025-08-01HUMAN PRESCRIPTION DRUG LABEL2