FDA.reportPublic FDA data

Buspirone hydrochloride

Product NDC
71610-959
11-digit product format
716100959
Labeler code
71610
Product ID
71610-959_45a02819-f5c1-f623-e063-6294a90a1284
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA202087
Marketing category
ANDA
Marketing start
2025-09-18
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
71610-959-30Buspirone hydrochloride30 in 1 BOTTLETABLET302
71610-959-53Buspirone hydrochloride60 in 1 BOTTLETABLET602
71610-959-60Buspirone hydrochloride90 in 1 BOTTLETABLET902
71610-959-80Buspirone hydrochloride180 in 1 BOTTLETABLET1802
71610-959-92Buspirone hydrochloride270 in 1 BOTTLETABLET2702

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-959-30EA - Each71610-9595d41ef7d-f11f-44d3-805e-c402b8e8f5a012025-12-16
71610-959-53EA - Each71610-959429b3180-e47c-4ef8-96e6-fb35202f0a5212025-12-16
71610-959-60EA - Each71610-959572b9c19-8cb1-4826-a2a0-e0936e46517512025-12-16
71610-959-80EA - Each71610-9592da40f81-8a01-4bcc-8229-9c05f601d7ac12025-12-16
71610-959-92EA - Each71610-959e5dedb82-dc21-4fca-beaf-4fa0f45eb9cd12026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866094busPIRone HCl 5 MG Oral TabletPSN424d81f0-b195-5bc2-e063-6394a90a21042
866094buspirone hydrochloride 5 MG Oral TabletSCD424d81f0-b195-5bc2-e063-6394a90a21042
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY424d81f0-b195-5bc2-e063-6394a90a21042

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-959-307161009593030 TABLET in 1 BOTTLE (71610-959-30) 30 tablet2025-10-28NoNoHistorical
71610-959-537161009595360 TABLET in 1 BOTTLE (71610-959-53) 60 tablet2025-10-28NoNoHistorical
71610-959-607161009596090 TABLET in 1 BOTTLE (71610-959-60) 90 tablet2025-10-28NoNoHistorical
71610-959-8071610095980180 TABLET in 1 BOTTLE (71610-959-80) 180 tablet2025-10-28NoNoHistorical
71610-959-9271610095992270 TABLET in 1 BOTTLE (71610-959-92) 270 tablet2025-12-09NoNoHistorical