Buspirone Hydrochloride

Product NDC
71610-203
11-digit product format
716100203
Labeler code
71610
Product ID
71610-203_3837aaad-61a9-4f61-ac1a-022302c51d21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075022
Marketing category
ANDA
Marketing start
2002-02-28
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
5 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 HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866094

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
71610-203-53Buspirone Hydrochloride60 in 1 BOTTLETABLET602
71610-203-60Buspirone Hydrochloride90 in 1 BOTTLETABLET902
71610-203-80Buspirone Hydrochloride180 in 1 BOTTLETABLET1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-203-53EA - Each71610-20308eda7dc-59b0-41e1-8c81-b195bc1f21f212019-02-13
71610-203-60EA - Each71610-203a81fca8e-786d-4955-8d04-402dd2afc64d12019-02-13
71610-203-80EA - Each71610-203dd26f1ab-0b5f-487c-aec2-262de4a8e1f312019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-203BUSPIRONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 3 package rows20190109_efa03f52-430e-455a-bdca-7f9d422b7b19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866094busPIRone HCl 5 MG Oral TabletPSNefa03f52-430e-455a-bdca-7f9d422b7b192
866094buspirone hydrochloride 5 MG Oral TabletSCDefa03f52-430e-455a-bdca-7f9d422b7b192
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSYefa03f52-430e-455a-bdca-7f9d422b7b192

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-203-537161002035360 TABLET in 1 BOTTLE (71610-203-53) 60 tablet2018-12-030000-00-00NoNoCurrent
71610-203-607161002036090 TABLET in 1 BOTTLE (71610-203-60) 90 tablet2018-12-030000-00-00NoNoCurrent
71610-203-8071610020380180 TABLET in 1 BOTTLE (71610-203-80) 180 tablet2018-12-030000-00-00NoNoCurrent