FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
71335-1105
11-digit product format
713351105
Labeler code
71335
Product ID
71335-1105_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
10 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 HYDROCHLORIDE10 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
71335-1105-1Buspirone Hydrochloride30 in 1 BOTTLETABLET306
71335-1105-2Buspirone Hydrochloride60 in 1 BOTTLETABLET606
71335-1105-3Buspirone Hydrochloride90 in 1 BOTTLETABLET906
71335-1105-4Buspirone Hydrochloride45 in 1 BOTTLETABLET456
71335-1105-5Buspirone Hydrochloride180 in 1 BOTTLETABLET1806
71335-1105-6Buspirone Hydrochloride120 in 1 BOTTLETABLET1206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1105BUSPIRONE 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 startMarketing endSampleExclude flagStatus
71335-1105-17133511050130 TABLET in 1 BOTTLE (71335-1105-1) 30 tablet2006-08-070000-00-00NoNoCurrent
71335-1105-27133511050260 TABLET in 1 BOTTLE (71335-1105-2) 60 tablet2006-08-070000-00-00NoNoCurrent
71335-1105-37133511050390 TABLET in 1 BOTTLE (71335-1105-3) 90 tablet2006-08-070000-00-00NoNoCurrent
71335-1105-47133511050445 TABLET in 1 BOTTLE (71335-1105-4) 45 tablet2006-08-070000-00-00NoNoCurrent
71335-1105-571335110505180 TABLET in 1 BOTTLE (71335-1105-5) 180 tablet2006-08-070000-00-00NoNoCurrent
71335-1105-671335110506120 TABLET in 1 BOTTLE (71335-1105-6) 120 tablet2006-08-070000-00-00NoNoCurrent