FDA.reportPublic FDA data

Buspirone hydrochloride

Product NDC
11788-059
11-digit product format
117880059
Labeler code
11788
Product ID
11788-059_fe9868fd-eb67-48a4-99a3-f25125507e36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
AiPing Pharmaceutical, Inc.
Application
ANDA202087
Marketing category
ANDA
Marketing start
2025-09-26
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866018, 866083, 866090, 866094, 866111

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
11788-059-01Buspirone hydrochloride100 in 1 BOTTLETABLET1001
11788-059-05Buspirone hydrochloride500 in 1 BOTTLETABLET5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11788-059-01EA - Each11788-059fc6c8ccd-b290-4db2-ac9b-0e7657e8cdde12025-11-13
11788-059-05EA - Each11788-0599a4bb4dd-d2ae-4a22-ba09-625a848ac0f112025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN55810b17-4796-49d0-90e4-8e075d62eda41
866018busPIRone HCl 15 MG Oral TabletPSN55810b17-4796-49d0-90e4-8e075d62eda41
866090busPIRone HCl 30 MG Oral TabletPSN55810b17-4796-49d0-90e4-8e075d62eda41
866094busPIRone HCl 5 MG Oral TabletPSN55810b17-4796-49d0-90e4-8e075d62eda41
866111busPIRone HCl 7.5 MG Oral TabletPSN55810b17-4796-49d0-90e4-8e075d62eda41
866083buspirone hydrochloride 10 MG Oral TabletSCD55810b17-4796-49d0-90e4-8e075d62eda41
866018buspirone hydrochloride 15 MG Oral TabletSCD55810b17-4796-49d0-90e4-8e075d62eda41
866090buspirone hydrochloride 30 MG Oral TabletSCD55810b17-4796-49d0-90e4-8e075d62eda41
866094buspirone hydrochloride 5 MG Oral TabletSCD55810b17-4796-49d0-90e4-8e075d62eda41
866111buspirone hydrochloride 7.5 MG Oral TabletSCD55810b17-4796-49d0-90e4-8e075d62eda41
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY55810b17-4796-49d0-90e4-8e075d62eda41
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSY55810b17-4796-49d0-90e4-8e075d62eda41
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY55810b17-4796-49d0-90e4-8e075d62eda41
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY55810b17-4796-49d0-90e4-8e075d62eda41
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY55810b17-4796-49d0-90e4-8e075d62eda41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11788-059-0111788005901100 TABLET in 1 BOTTLE (11788-059-01) 100 tablet2025-09-26NoNoHistorical
11788-059-0511788005905500 TABLET in 1 BOTTLE (11788-059-05) 500 tablet2025-09-26NoNoHistorical