FDA.reportPublic FDA data

Buspirone hydrochloride

Product NDC
71610-962
11-digit product format
716100962
Labeler code
71610
Product ID
71610-962_47e30f25-1be3-1cd2-e063-6294a90ae97f
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
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 hydrochloride
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
71610-962-53Buspirone hydrochloride60 in 1 BOTTLETABLET603
71610-962-60Buspirone hydrochloride90 in 1 BOTTLETABLET903
71610-962-70Buspirone hydrochloride120 in 1 BOTTLETABLET1203
71610-962-80Buspirone hydrochloride180 in 1 BOTTLETABLET1803
71610-962-92Buspirone hydrochloride270 in 1 BOTTLETABLET2703

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-962-53EA - Each71610-962bfb1b8db-331d-489e-81f1-0a98ac6f6cba12025-12-16
71610-962-60EA - Each71610-9626f97948d-c11e-4bb9-890a-758a29233ebd12025-12-16
71610-962-70EA - Each71610-9627159ec11-0418-47d0-81e1-d9f2eae2647a12026-03-17
71610-962-80EA - Each71610-9621baae621-d156-400f-a99c-bb66684ae25912025-12-16
71610-962-92EA - Each71610-9623087c88d-7408-4319-987c-cb651b46283b12026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN427ad27e-6664-afee-e063-6394a90a18903
866083buspirone hydrochloride 10 MG Oral TabletSCD427ad27e-6664-afee-e063-6394a90a18903
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY427ad27e-6664-afee-e063-6394a90a18903

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-962-537161009625360 TABLET in 1 BOTTLE (71610-962-53) 60 tablet2025-11-05NoNoHistorical
71610-962-607161009626090 TABLET in 1 BOTTLE (71610-962-60) 90 tablet2025-10-31NoNoHistorical
71610-962-7071610096270120 TABLET in 1 BOTTLE (71610-962-70) 120 tablet2026-01-08NoNoHistorical
71610-962-8071610096280180 TABLET in 1 BOTTLE (71610-962-80) 180 tablet2025-11-05NoNoHistorical
71610-962-9271610096292270 TABLET in 1 BOTTLE (71610-962-92) 270 tablet2026-01-08NoNoHistorical