FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
69584-093
11-digit product format
695840093
Labeler code
69584
Product ID
69584-093_8c9f66ca-78a9-418c-b11e-ba4391843257
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Oxford Pharmaceuticals, LLC
Application
ANDA075388
Marketing category
ANDA
Marketing start
2020-07-27
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
15 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 HYDROCHLORIDE15 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
69584-093-06Buspirone Hydrochloride60 in 1 BOTTLETABLET606
69584-093-10Buspirone Hydrochloride100 in 1 BOTTLETABLET1006
69584-093-50Buspirone Hydrochloride500 in 1 BOTTLETABLET5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69584-093-06EA - Each69584-093768dd759-88c7-45b5-b4c8-023cf5d56ab212025-09-12
69584-093-10EA - Each69584-093cb8c0cbc-01da-4124-a7bb-0d390306daa612020-09-14
69584-093-50EA - Each69584-0934f55469a-f28c-44ed-b378-03be51bb408612020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69584-093BUSPIRONE HYDROCHLORIDE TABLET [OXFORD PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 3 package rows20240207_97fcebc1-6615-4b9d-b0f3-6434850f407c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866018busPIRone HCl 15 MG Oral TabletPSN2a8b3b75-5d93-4a9e-a583-49ccddd65650105
866018buspirone hydrochloride 15 MG Oral TabletSCD2a8b3b75-5d93-4a9e-a583-49ccddd65650105
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY2a8b3b75-5d93-4a9e-a583-49ccddd65650105
866018busPIRone HCl 15 MG Oral TabletPSNf85b59b7-b945-4440-8378-987bd287a655104
866018busPIRone HCl 15 MG Oral TabletPSN65c69118-36bb-4f0d-9669-b52556056ec5104
866018buspirone hydrochloride 15 MG Oral TabletSCDf85b59b7-b945-4440-8378-987bd287a655104
866018buspirone hydrochloride 15 MG Oral TabletSCD65c69118-36bb-4f0d-9669-b52556056ec5104
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYf85b59b7-b945-4440-8378-987bd287a655104
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY65c69118-36bb-4f0d-9669-b52556056ec5104
866018busPIRone HCl 15 MG Oral TabletPSN49659ee7-ca08-4df1-8e6b-3a366a7839c7103
866018buspirone hydrochloride 15 MG Oral TabletSCD49659ee7-ca08-4df1-8e6b-3a366a7839c7103
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY49659ee7-ca08-4df1-8e6b-3a366a7839c7103
866083busPIRone HCl 10 MG Oral TabletPSN476f4f55-c6c1-4f39-950e-59236f49957718
866018busPIRone HCl 15 MG Oral TabletPSN476f4f55-c6c1-4f39-950e-59236f49957718
866090busPIRone HCl 30 MG Oral TabletPSN476f4f55-c6c1-4f39-950e-59236f49957718
866094busPIRone HCl 5 MG Oral TabletPSN476f4f55-c6c1-4f39-950e-59236f49957718
866083buspirone hydrochloride 10 MG Oral TabletSCD476f4f55-c6c1-4f39-950e-59236f49957718
866018buspirone hydrochloride 15 MG Oral TabletSCD476f4f55-c6c1-4f39-950e-59236f49957718
866090buspirone hydrochloride 30 MG Oral TabletSCD476f4f55-c6c1-4f39-950e-59236f49957718
866094buspirone hydrochloride 5 MG Oral TabletSCD476f4f55-c6c1-4f39-950e-59236f49957718
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY476f4f55-c6c1-4f39-950e-59236f49957718
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY476f4f55-c6c1-4f39-950e-59236f49957718
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY476f4f55-c6c1-4f39-950e-59236f49957718
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY476f4f55-c6c1-4f39-950e-59236f49957718
866018busPIRone HCl 15 MG Oral TabletPSN270398a0-21b8-407b-af76-4aeef90f72be8
866018buspirone hydrochloride 15 MG Oral TabletSCD270398a0-21b8-407b-af76-4aeef90f72be8
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY270398a0-21b8-407b-af76-4aeef90f72be8
866018busPIRone HCl 15 MG Oral TabletPSN3155e607-bc7f-4e90-9edf-8e862dd5737d7
866018buspirone hydrochloride 15 MG Oral TabletSCD3155e607-bc7f-4e90-9edf-8e862dd5737d7
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY3155e607-bc7f-4e90-9edf-8e862dd5737d7
866083busPIRone HCl 10 MG Oral TabletPSN97fcebc1-6615-4b9d-b0f3-6434850f407c6
866018busPIRone HCl 15 MG Oral TabletPSN97fcebc1-6615-4b9d-b0f3-6434850f407c6
866090busPIRone HCl 30 MG Oral TabletPSN97fcebc1-6615-4b9d-b0f3-6434850f407c6
866094busPIRone HCl 5 MG Oral TabletPSN97fcebc1-6615-4b9d-b0f3-6434850f407c6
866083buspirone hydrochloride 10 MG Oral TabletSCD97fcebc1-6615-4b9d-b0f3-6434850f407c6
866018buspirone hydrochloride 15 MG Oral TabletSCD97fcebc1-6615-4b9d-b0f3-6434850f407c6
866090buspirone hydrochloride 30 MG Oral TabletSCD97fcebc1-6615-4b9d-b0f3-6434850f407c6
866094buspirone hydrochloride 5 MG Oral TabletSCD97fcebc1-6615-4b9d-b0f3-6434850f407c6
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY97fcebc1-6615-4b9d-b0f3-6434850f407c6
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY97fcebc1-6615-4b9d-b0f3-6434850f407c6
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY97fcebc1-6615-4b9d-b0f3-6434850f407c6
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY97fcebc1-6615-4b9d-b0f3-6434850f407c6
866018busPIRone HCl 15 MG Oral TabletPSN84621631-4c13-4147-ae3c-4ed30d4ebb374
866018buspirone hydrochloride 15 MG Oral TabletSCD84621631-4c13-4147-ae3c-4ed30d4ebb374
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY84621631-4c13-4147-ae3c-4ed30d4ebb374
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 startMarketing endSampleExclude flagStatus
69584-093-066958400930660 TABLET in 1 BOTTLE (69584-093-06) 60 tablet2025-08-24NoNoCurrent
69584-093-1069584009310100 TABLET in 1 BOTTLE (69584-093-10) 100 tablet2020-07-270000-00-00NoNoCurrent
69584-093-5069584009350500 TABLET in 1 BOTTLE (69584-093-50) 500 tablet2020-07-270000-00-00NoNoCurrent