FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
82804-964
11-digit product format
828040964
Labeler code
82804
Product ID
82804-964_1521109d-8386-472f-9483-f1fe9f7ed152
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078302
Marketing category
ANDA
Marketing start
2020-05-01
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
30 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 HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

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

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
82804-964-00Buspirone Hydrochloride100 in 1 BOTTLETABLET1001
82804-964-11Buspirone Hydrochloride1000 in 1 BOTTLETABLET10001
82804-964-30Buspirone Hydrochloride30 in 1 BOTTLETABLET301
82804-964-55Buspirone Hydrochloride500 in 1 BOTTLETABLET5001
82804-964-60Buspirone Hydrochloride60 in 1 BOTTLETABLET601
82804-964-72Buspirone Hydrochloride120 in 1 BOTTLETABLET1201
82804-964-90Buspirone Hydrochloride90 in 1 BOTTLETABLET901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN1521109d-8386-472f-9483-f1fe9f7ed1521
866018busPIRone HCl 15 MG Oral TabletPSN1521109d-8386-472f-9483-f1fe9f7ed1521
866090busPIRone HCl 30 MG Oral TabletPSN1521109d-8386-472f-9483-f1fe9f7ed1521
866094busPIRone HCl 5 MG Oral TabletPSN1521109d-8386-472f-9483-f1fe9f7ed1521
866083buspirone hydrochloride 10 MG Oral TabletSCD1521109d-8386-472f-9483-f1fe9f7ed1521
866018buspirone hydrochloride 15 MG Oral TabletSCD1521109d-8386-472f-9483-f1fe9f7ed1521
866090buspirone hydrochloride 30 MG Oral TabletSCD1521109d-8386-472f-9483-f1fe9f7ed1521
866094buspirone hydrochloride 5 MG Oral TabletSCD1521109d-8386-472f-9483-f1fe9f7ed1521
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY1521109d-8386-472f-9483-f1fe9f7ed1521
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY1521109d-8386-472f-9483-f1fe9f7ed1521
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY1521109d-8386-472f-9483-f1fe9f7ed1521
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY1521109d-8386-472f-9483-f1fe9f7ed1521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-964-0082804096400100 TABLET in 1 BOTTLE (82804-964-00) 100 tablet2026-01-12NoNoCurrent
82804-964-11828040964111000 TABLET in 1 BOTTLE (82804-964-11) 1000 tablet2026-01-12NoNoCurrent
82804-964-308280409643030 TABLET in 1 BOTTLE (82804-964-30) 30 tablet2026-01-12NoNoCurrent
82804-964-5582804096455500 TABLET in 1 BOTTLE (82804-964-55) 500 tablet2026-01-12NoNoCurrent
82804-964-608280409646060 TABLET in 1 BOTTLE (82804-964-60) 60 tablet2026-01-12NoNoCurrent
82804-964-7282804096472120 TABLET in 1 BOTTLE (82804-964-72) 120 tablet2026-01-12NoNoCurrent
82804-964-908280409649090 TABLET in 1 BOTTLE (82804-964-90) 90 tablet2026-01-12NoNoCurrent