Buspirone Hydrochloride

Product NDC
71335-2510
11-digit product format
713352510
Labeler code
71335
Product ID
71335-2510_822cef27-4fa5-4657-bb0b-4ca16ef37079
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075022
Marketing category
ANDA
Marketing start
2004-03-26
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
30 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA Listing Details

Product ID
71335-2510_822cef27-4fa5-4657-bb0b-4ca16ef37079
SPL ID
822cef27-4fa5-4657-bb0b-4ca16ef37079
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
Buspirone Hydrochloride
Generic name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Marketing start
2004-03-26
Marketing category
ANDA
Application number
ANDA075022
Listing expiration
2026-12-31

openFDA Active Ingredients

IngredientStrength
BUSPIRONE HYDROCHLORIDE30 mg/1

openFDA Harmonized Identifiers

FieldValues
Unii207LT9J9OC
Rxcui866090
Spl Set Ida8720833-3bbc-4714-b9b8-716c5e55410d
Manufacturer NameBryant Ranch Prepack

openFDA Package Details

Package NDCDescriptionMarketing startSample
71335-2510-160 TABLET in 1 BOTTLE (71335-2510-1)2024-10-21No
71335-2510-230 TABLET in 1 BOTTLE (71335-2510-2)2024-10-21No
71335-2510-356 TABLET in 1 BOTTLE (71335-2510-3)2024-10-21No
71335-2510-490 TABLET in 1 BOTTLE (71335-2510-4)2024-10-21No
71335-2510-5180 TABLET in 1 BOTTLE (71335-2510-5)2024-10-21No
71335-2510-615 TABLET in 1 BOTTLE (71335-2510-6)2024-10-21No
71335-2510-7120 TABLET in 1 BOTTLE (71335-2510-7)2024-10-21No

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
207LT9J9OCBUSPIRONE HYDROCHLORIDE33386-08-2BUSPIRONE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2510-17133525100160 TABLET in 1 BOTTLE (71335-2510-1) 60 tablet2024-10-21NoNoHistorical
71335-2510-27133525100230 TABLET in 1 BOTTLE (71335-2510-2) 30 tablet2024-10-21NoNoHistorical
71335-2510-37133525100356 TABLET in 1 BOTTLE (71335-2510-3) 56 tablet2024-10-21NoNoHistorical
71335-2510-47133525100490 TABLET in 1 BOTTLE (71335-2510-4) 90 tablet2024-10-21NoNoHistorical
71335-2510-571335251005180 TABLET in 1 BOTTLE (71335-2510-5) 180 tablet2024-10-21NoNoHistorical
71335-2510-67133525100615 TABLET in 1 BOTTLE (71335-2510-6) 15 tablet2024-10-21NoNoHistorical
71335-2510-771335251007120 TABLET in 1 BOTTLE (71335-2510-7) 120 tablet2024-10-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
BusPIRone Hydrochloride Tablets, USP Rx onlyBryant Ranch Prepack2024-10-21HUMAN PRESCRIPTION DRUG LABEL1