FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
71335-2458
11-digit product format
713352458
Labeler code
71335
Product ID
71335-2458_1fb03366-6bc1-49fa-80f4-f2afeaac9d01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210907
Marketing category
ANDA
Marketing start
2023-10-17
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
71335-2458-1Buspirone Hydrochloride60 in 1 BOTTLE, PLASTICTABLET601
71335-2458-2Buspirone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET301
71335-2458-3Buspirone Hydrochloride56 in 1 BOTTLE, PLASTICTABLET561
71335-2458-4Buspirone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET901
71335-2458-5Buspirone Hydrochloride180 in 1 BOTTLE, PLASTICTABLET1801
71335-2458-6Buspirone Hydrochloride15 in 1 BOTTLE, PLASTICTABLET151
71335-2458-7Buspirone Hydrochloride120 in 1 BOTTLE, PLASTICTABLET1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2458-6EA - Each71335-24588b9951a9-861b-4800-9429-c6a0f8b151a412026-01-08
71335-2458-7EA - Each71335-24587d4c9820-cc56-48e7-b91f-7c983f1fdec212026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2458BUSPIRONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1Current NDC, 7 package rows20240823_38faa7cb-d858-4481-8649-35d228acbd38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866090busPIRone HCl 30 MG Oral TabletPSN38faa7cb-d858-4481-8649-35d228acbd381
866090buspirone hydrochloride 30 MG Oral TabletSCD38faa7cb-d858-4481-8649-35d228acbd381
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY38faa7cb-d858-4481-8649-35d228acbd381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2458-17133524580160 TABLET in 1 BOTTLE, PLASTIC (71335-2458-1) 60 tablet2024-08-20NoNoHistorical
71335-2458-27133524580230 TABLET in 1 BOTTLE, PLASTIC (71335-2458-2) 30 tablet2024-08-20NoNoHistorical
71335-2458-37133524580356 TABLET in 1 BOTTLE, PLASTIC (71335-2458-3) 56 tablet2024-08-20NoNoHistorical
71335-2458-47133524580490 TABLET in 1 BOTTLE, PLASTIC (71335-2458-4) 90 tablet2024-08-20NoNoHistorical
71335-2458-571335245805180 TABLET in 1 BOTTLE, PLASTIC (71335-2458-5) 180 tablet2024-08-20NoNoHistorical
71335-2458-67133524580615 TABLET in 1 BOTTLE, PLASTIC (71335-2458-6) 15 tablet2024-08-20NoNoHistorical
71335-2458-771335245807120 TABLET in 1 BOTTLE, PLASTIC (71335-2458-7) 120 tablet2024-08-20NoNoHistorical