FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
71610-943
11-digit product format
716100943
Labeler code
71610
Product ID
71610-943_3e4b22e7-e800-e5b1-e063-6294a90a6d49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075388
Marketing category
ANDA
Marketing start
2020-07-27
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
71610-943-53Buspirone Hydrochloride60 in 1 BOTTLETABLET602
71610-943-60Buspirone Hydrochloride90 in 1 BOTTLETABLET902
71610-943-80Buspirone Hydrochloride180 in 1 BOTTLETABLET1802
71610-943-92Buspirone Hydrochloride270 in 1 BOTTLETABLET2702

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-943-53EA - Each71610-9430fb4ed43-520c-4c13-84f0-bce3ea81c1aa12025-10-14
71610-943-60EA - Each71610-9439471d51f-412f-42c4-ba1c-fe71215c175912025-10-14
71610-943-80EA - Each71610-94342315a2b-b15b-46a9-a3f1-b6cbbb00473112025-10-14
71610-943-92EA - Each71610-943e440d354-d394-45ab-9e3e-f7e717cddb5312025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866094busPIRone HCl 5 MG Oral TabletPSN3dd7f213-afd8-67d6-e063-6294a90ac1082
866094buspirone hydrochloride 5 MG Oral TabletSCD3dd7f213-afd8-67d6-e063-6294a90ac1082
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY3dd7f213-afd8-67d6-e063-6294a90ac1082

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-943-537161009435360 TABLET in 1 BOTTLE (71610-943-53) 60 tablet2025-09-02NoNoHistorical
71610-943-607161009436090 TABLET in 1 BOTTLE (71610-943-60) 90 tablet2025-09-02NoNoHistorical
71610-943-8071610094380180 TABLET in 1 BOTTLE (71610-943-80) 180 tablet2025-09-02NoNoHistorical
71610-943-9271610094392270 TABLET in 1 BOTTLE (71610-943-92) 270 tablet2025-09-03NoNoHistorical