FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
71610-974
11-digit product format
716100974
Labeler code
71610
Product ID
71610-974_4df36eb1-1f18-3857-e063-6394a90a1c89
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
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
71610-974-30Buspirone Hydrochloride30 in 1 BOTTLETABLET302
71610-974-53Buspirone Hydrochloride60 in 1 BOTTLETABLET602
71610-974-60Buspirone Hydrochloride90 in 1 BOTTLETABLET902
71610-974-70Buspirone Hydrochloride120 in 1 BOTTLETABLET1202
71610-974-80Buspirone Hydrochloride180 in 1 BOTTLETABLET1802
71610-974-92Buspirone Hydrochloride270 in 1 BOTTLETABLET2702

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-974-30EA - Each71610-9741b5829c7-e107-404d-837c-70a56bc33ec712026-03-17
71610-974-53EA - Each71610-9744de31244-7049-4fb7-b03e-da83ec7dbf7e12026-03-17
71610-974-60EA - Each71610-974823d87ff-84a1-4b16-b31d-c3357e2e464212026-03-17
71610-974-70EA - Each71610-97470b4e93b-8a6e-4bbe-bbb2-cc2b1c27501312026-05-22
71610-974-80EA - Each71610-9746cf06949-ceb4-4995-84ad-9d133bf398ff12026-03-17
71610-974-92EA - Each71610-974be7f4027-2006-40f7-9f1c-06e0740aa9cf12026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN459cc50d-0b18-ac1d-e063-6294a90ae7c42
866083buspirone hydrochloride 10 MG Oral TabletSCD459cc50d-0b18-ac1d-e063-6294a90ae7c42
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY459cc50d-0b18-ac1d-e063-6294a90ae7c42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-974-307161009743030 TABLET in 1 BOTTLE (71610-974-30) 30 tablet2025-12-09NoNoHistorical
71610-974-537161009745360 TABLET in 1 BOTTLE (71610-974-53) 60 tablet2025-12-09NoNoHistorical
71610-974-607161009746090 TABLET in 1 BOTTLE (71610-974-60) 90 tablet2025-12-09NoNoHistorical
71610-974-7071610097470120 TABLET in 1 BOTTLE (71610-974-70) 120 tablet2026-03-26NoNoHistorical
71610-974-8071610097480180 TABLET in 1 BOTTLE (71610-974-80) 180 tablet2025-12-09NoNoHistorical
71610-974-9271610097492270 TABLET in 1 BOTTLE (71610-974-92) 270 tablet2025-12-09NoNoHistorical