FDA.reportPublic FDA data

busPIRone HCl

Product NDC
71335-9758
11-digit product format
713359758
Labeler code
71335
Product ID
71335-9758_58de542f-8f84-4d8d-b922-0ca2293f1e66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075521
Marketing category
ANDA
Marketing start
2020-12-29
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
busPIRone HCl
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUSPIRONE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866083

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
71335-9758-1busPIRone HCl30 in 1 BOTTLETABLET30101
71335-9758-2busPIRone HCl60 in 1 BOTTLETABLET60101
71335-9758-3busPIRone HCl90 in 1 BOTTLETABLET90101
71335-9758-4busPIRone HCl45 in 1 BOTTLETABLET45101
71335-9758-5busPIRone HCl180 in 1 BOTTLETABLET180101
71335-9758-6busPIRone HCl120 in 1 BOTTLETABLET120101
71335-9758-7busPIRone HCl10 in 1 BOTTLETABLET10101
71335-9758-8busPIRone HCl100 in 1 BOTTLETABLET100101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9758BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]100Current NDC, 8 package rows20230726_138b84a5-966b-47d7-a3d6-395df83f8aa5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN138b84a5-966b-47d7-a3d6-395df83f8aa5101
866083buspirone hydrochloride 10 MG Oral TabletSCD138b84a5-966b-47d7-a3d6-395df83f8aa5101
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY138b84a5-966b-47d7-a3d6-395df83f8aa5101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9758-17133597580130 TABLET in 1 BOTTLE (71335-9758-1) 30 tablet2023-10-04NoNoHistorical
71335-9758-27133597580260 TABLET in 1 BOTTLE (71335-9758-2) 60 tablet2023-11-30NoNoHistorical
71335-9758-37133597580390 TABLET in 1 BOTTLE (71335-9758-3) 90 tablet2023-11-20NoNoHistorical
71335-9758-47133597580445 TABLET in 1 BOTTLE (71335-9758-4) 45 tablet2026-04-08NoNoHistorical
71335-9758-571335975805180 TABLET in 1 BOTTLE (71335-9758-5) 180 tablet2023-07-20NoNoHistorical
71335-9758-671335975806120 TABLET in 1 BOTTLE (71335-9758-6) 120 tablet2026-04-08NoNoHistorical
71335-9758-77133597580710 TABLET in 1 BOTTLE (71335-9758-7) 10 tablet2026-04-08NoNoHistorical
71335-9758-871335975808100 TABLET in 1 BOTTLE (71335-9758-8) 100 tablet2026-04-08NoNoHistorical