Buspirone Hydrochloride

Product NDC
82804-062
11-digit product format
828040062
Labeler code
82804
Product ID
82804-062_1886b672-4b88-4b49-ae6a-d2ba2f452e44
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
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
82804-062-308280400623030 TABLET in 1 BOTTLE, PLASTIC (82804-062-30) 30 tablet2024-01-26NoNoHistorical
82804-062-608280400626060 TABLET in 1 BOTTLE, PLASTIC (82804-062-60) 60 tablet2024-01-26NoNoHistorical
82804-062-908280400629090 TABLET in 1 BOTTLE, PLASTIC (82804-062-90) 90 tablet2024-01-26NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Buspirone Hydrochloride Tablets, USP Rx OnlyProficient Rx LP2024-01-01HUMAN PRESCRIPTION DRUG LABEL1