Buspirone Hydrochloride

Product NDC
71335-1144
11-digit product format
713351144
Labeler code
71335
Product ID
71335-1144_642c0480-01e4-4770-88e4-d2644656f3f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209696
Marketing category
ANDA
Marketing start
2024-06-17
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

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1144-1Buspirone Hydrochloride30 in 1 BOTTLETABLET303
71335-1144-2Buspirone Hydrochloride60 in 1 BOTTLETABLET603
71335-1144-3Buspirone Hydrochloride90 in 1 BOTTLETABLET903
71335-1144-4Buspirone Hydrochloride45 in 1 BOTTLETABLET453
71335-1144-5Buspirone Hydrochloride180 in 1 BOTTLETABLET1803
71335-1144-6Buspirone Hydrochloride120 in 1 BOTTLETABLET1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1144BUSPIRONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 6 package rows20240724_267d8897-90dd-4f8a-bbd8-8aa4e47c2905.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN267d8897-90dd-4f8a-bbd8-8aa4e47c29053
866083buspirone hydrochloride 10 MG Oral TabletSCD267d8897-90dd-4f8a-bbd8-8aa4e47c29053
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY267d8897-90dd-4f8a-bbd8-8aa4e47c29053

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1144-17133511440130 TABLET in 1 BOTTLE (71335-1144-1) 30 tablet2024-07-090000-00-00NoNoCurrent
71335-1144-27133511440260 TABLET in 1 BOTTLE (71335-1144-2) 60 tablet2024-07-090000-00-00NoNoCurrent
71335-1144-37133511440390 TABLET in 1 BOTTLE (71335-1144-3) 90 tablet2024-07-090000-00-00NoNoCurrent
71335-1144-47133511440445 TABLET in 1 BOTTLE (71335-1144-4) 45 tablet2024-07-090000-00-00NoNoCurrent
71335-1144-571335114405180 TABLET in 1 BOTTLE (71335-1144-5) 180 tablet2024-07-090000-00-00NoNoCurrent
71335-1144-671335114406120 TABLET in 1 BOTTLE (71335-1144-6) 120 tablet2024-07-090000-00-00NoNoCurrent