FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
69584-094
11-digit product format
695840094
Labeler code
69584
Product ID
69584-094_8c9f66ca-78a9-418c-b11e-ba4391843257
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Oxford Pharmaceuticals, LLC
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
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 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
69584-094-06Buspirone Hydrochloride60 in 1 BOTTLETABLET606
69584-094-18Buspirone Hydrochloride180 in 1 BOTTLETABLET1806
69584-094-50Buspirone Hydrochloride500 in 1 BOTTLETABLET5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69584-094-50EA - Each69584-0940ef85062-5889-4bcc-9455-5a3ed5b2b3fd12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69584-094BUSPIRONE 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
866090busPIRone HCl 30 MG Oral TabletPSN8bb7991e-ab09-4602-b49d-0a72a501685b106
866090buspirone hydrochloride 30 MG Oral TabletSCD8bb7991e-ab09-4602-b49d-0a72a501685b106
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY8bb7991e-ab09-4602-b49d-0a72a501685b106
866090busPIRone HCl 30 MG Oral TabletPSN696911d8-e97a-4c8e-9341-782b4c63bf03105
866090buspirone hydrochloride 30 MG Oral TabletSCD696911d8-e97a-4c8e-9341-782b4c63bf03105
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY696911d8-e97a-4c8e-9341-782b4c63bf03105
866090busPIRone HCl 30 MG Oral TabletPSNeb072818-3ca8-430b-91a1-e7fedd37990c102
866090buspirone hydrochloride 30 MG Oral TabletSCDeb072818-3ca8-430b-91a1-e7fedd37990c102
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSYeb072818-3ca8-430b-91a1-e7fedd37990c102
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
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
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
866090busPIRone HCl 30 MG Oral TabletPSN790b6159-c03b-4a3a-be6b-add35a3114a41
866090busPIRone HCl 30 MG Oral TabletPSN38677cd0-2ee6-4c8f-8553-36310b2813a11
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
866090buspirone hydrochloride 30 MG Oral TabletSCD38677cd0-2ee6-4c8f-8553-36310b2813a11
866090buspirone hydrochloride 30 MG Oral TabletSCD790b6159-c03b-4a3a-be6b-add35a3114a41
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 TabletSY790b6159-c03b-4a3a-be6b-add35a3114a41
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY38677cd0-2ee6-4c8f-8553-36310b2813a11
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
69584-094-066958400940660 TABLET in 1 BOTTLE (69584-094-06) 60 tablet2020-05-010000-00-00NoNoCurrent
69584-094-1869584009418180 TABLET in 1 BOTTLE (69584-094-18) 180 tablet2020-05-010000-00-00NoNoCurrent
69584-094-5069584009450500 TABLET in 1 BOTTLE (69584-094-50) 500 tablet2020-05-010000-00-00NoNoCurrent