FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
71335-0253
11-digit product format
713350253
Labeler code
71335
Product ID
71335-0253_fa7aedac-e465-4ae7-b725-0d037f3d3668
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075022
Marketing category
ANDA
Marketing start
2002-02-28
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Buspirone Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUSPIRONE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866083, 866094

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a9968269-ddf2-400e-9170-7376dcf3545aProduct name120251215
2cf3c2e9-d566-c982-009a-188fe4f776b9Product name820200428
4a9096ce-7b98-89e5-5942-15f48c4f7abfProduct name520190711

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0253-1Buspirone Hydrochloride90 in 1 BOTTLETABLET906
71335-0253-2Buspirone Hydrochloride45 in 1 BOTTLETABLET456
71335-0253-3Buspirone Hydrochloride30 in 1 BOTTLETABLET306
71335-0253-4Buspirone Hydrochloride60 in 1 BOTTLETABLET606
71335-0253-5Buspirone Hydrochloride180 in 1 BOTTLETABLET1806
71335-0253-6Buspirone Hydrochloride120 in 1 BOTTLETABLET1206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0253BUSPIRONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 6 package rows20240724_db32a7ec-5b50-4305-8952-df22e7e871e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSNdb32a7ec-5b50-4305-8952-df22e7e871e26
866094busPIRone HCl 5 MG Oral TabletPSNdb32a7ec-5b50-4305-8952-df22e7e871e26
866083buspirone hydrochloride 10 MG Oral TabletSCDdb32a7ec-5b50-4305-8952-df22e7e871e26
866094buspirone hydrochloride 5 MG Oral TabletSCDdb32a7ec-5b50-4305-8952-df22e7e871e26
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYdb32a7ec-5b50-4305-8952-df22e7e871e26
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSYdb32a7ec-5b50-4305-8952-df22e7e871e26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-0253-17133502530190 TABLET in 1 BOTTLE (71335-0253-1) 90 tablet2024-07-09NoNoHistorical
71335-0253-27133502530245 TABLET in 1 BOTTLE (71335-0253-2) 45 tablet2024-07-09NoNoHistorical
71335-0253-37133502530330 TABLET in 1 BOTTLE (71335-0253-3) 30 tablet2024-07-09NoNoHistorical
71335-0253-47133502530460 TABLET in 1 BOTTLE (71335-0253-4) 60 tablet2018-03-05NoNoHistorical
71335-0253-571335025305180 TABLET in 1 BOTTLE (71335-0253-5) 180 tablet2024-07-09NoNoHistorical
71335-0253-671335025306120 TABLET in 1 BOTTLE (71335-0253-6) 120 tablet2024-07-09NoNoHistorical