FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
71335-2768
11-digit product format
713352768
Labeler code
71335
Product ID
71335-2768_98aa0336-0e99-4d64-a08e-0c96e49edf85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078302
Marketing category
ANDA
Marketing start
2020-05-01
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
30 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 HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866090

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
71335-2768-1Buspirone Hydrochloride60 in 1 BOTTLETABLET601
71335-2768-2Buspirone Hydrochloride30 in 1 BOTTLETABLET301
71335-2768-3Buspirone Hydrochloride56 in 1 BOTTLETABLET561
71335-2768-4Buspirone Hydrochloride90 in 1 BOTTLETABLET901
71335-2768-5Buspirone Hydrochloride180 in 1 BOTTLETABLET1801
71335-2768-6Buspirone Hydrochloride15 in 1 BOTTLETABLET151
71335-2768-7Buspirone Hydrochloride120 in 1 BOTTLETABLET1201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866090busPIRone HCl 30 MG Oral TabletPSN790b6159-c03b-4a3a-be6b-add35a3114a41
866090buspirone hydrochloride 30 MG Oral TabletSCD790b6159-c03b-4a3a-be6b-add35a3114a41
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY790b6159-c03b-4a3a-be6b-add35a3114a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2768-17133527680160 TABLET in 1 BOTTLE (71335-2768-1) 60 tablet2025-10-03NoNoHistorical
71335-2768-27133527680230 TABLET in 1 BOTTLE (71335-2768-2) 30 tablet2025-10-03NoNoHistorical
71335-2768-37133527680356 TABLET in 1 BOTTLE (71335-2768-3) 56 tablet2025-10-03NoNoHistorical
71335-2768-47133527680490 TABLET in 1 BOTTLE (71335-2768-4) 90 tablet2025-10-03NoNoHistorical
71335-2768-571335276805180 TABLET in 1 BOTTLE (71335-2768-5) 180 tablet2025-10-03NoNoHistorical
71335-2768-67133527680615 TABLET in 1 BOTTLE (71335-2768-6) 15 tablet2025-10-03NoNoHistorical
71335-2768-771335276807120 TABLET in 1 BOTTLE (71335-2768-7) 120 tablet2025-10-03NoNoHistorical