FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
69584-092
11-digit product format
695840092
Labeler code
69584
Product ID
69584-092_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
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

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
69584-092-10Buspirone Hydrochloride100 in 1 BOTTLETABLET1006
69584-092-50Buspirone Hydrochloride500 in 1 BOTTLETABLET5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69584-092-10EA - Each69584-0920a6d6bec-991b-46fb-aafb-a10c683e783f12020-09-14
69584-092-50EA - Each69584-092fb5e6c4d-3c4b-4df9-9619-96822d2602f412020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69584-092BUSPIRONE HYDROCHLORIDE TABLET [OXFORD PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 2 package rows20240207_97fcebc1-6615-4b9d-b0f3-6434850f407c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSNa738c103-134a-401f-b14c-49a599130b8d104
866083busPIRone HCl 10 MG Oral TabletPSNad651fd5-fd91-4517-8de7-6fafd15ac7eb104
866083buspirone hydrochloride 10 MG Oral TabletSCDa738c103-134a-401f-b14c-49a599130b8d104
866083buspirone hydrochloride 10 MG Oral TabletSCDad651fd5-fd91-4517-8de7-6fafd15ac7eb104
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYa738c103-134a-401f-b14c-49a599130b8d104
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYad651fd5-fd91-4517-8de7-6fafd15ac7eb104
866083busPIRone HCl 10 MG Oral TabletPSN4e7640d1-0a31-4f97-82bb-574cf1ff6e4a103
866083busPIRone HCl 10 MG Oral TabletPSNaba814f0-55ce-4480-99f1-b9ad1ba77d3f103
866083buspirone hydrochloride 10 MG Oral TabletSCD4e7640d1-0a31-4f97-82bb-574cf1ff6e4a103
866083buspirone hydrochloride 10 MG Oral TabletSCDaba814f0-55ce-4480-99f1-b9ad1ba77d3f103
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY4e7640d1-0a31-4f97-82bb-574cf1ff6e4a103
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYaba814f0-55ce-4480-99f1-b9ad1ba77d3f103
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 TabletPSNb217f341-7d51-475d-887f-f16786164c7b11
866083buspirone hydrochloride 10 MG Oral TabletSCDb217f341-7d51-475d-887f-f16786164c7b11
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYb217f341-7d51-475d-887f-f16786164c7b11
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 TabletPSNe4d44e49-eb8f-454e-a737-22caf30bda783
866083buspirone hydrochloride 10 MG Oral TabletSCDe4d44e49-eb8f-454e-a737-22caf30bda783
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYe4d44e49-eb8f-454e-a737-22caf30bda783
866083busPIRone HCl 10 MG Oral TabletPSN338f3317-96c0-4b8a-8299-8ce2a10911ae1
866083busPIRone HCl 10 MG Oral TabletPSNef8fc378-7fee-4d20-81ec-31211e34dc6e1
866083busPIRone HCl 10 MG Oral TabletPSN1521109d-8386-472f-9483-f1fe9f7ed1521
866083busPIRone HCl 10 MG Oral TabletPSN40d5813d-d040-002c-e063-6294a90a5f7a1
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 TabletSCD40d5813d-d040-002c-e063-6294a90a5f7a1
866083buspirone hydrochloride 10 MG Oral TabletSCD338f3317-96c0-4b8a-8299-8ce2a10911ae1
866083buspirone hydrochloride 10 MG Oral TabletSCD1521109d-8386-472f-9483-f1fe9f7ed1521
866083buspirone hydrochloride 10 MG Oral TabletSCDef8fc378-7fee-4d20-81ec-31211e34dc6e1
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 TabletSY40d5813d-d040-002c-e063-6294a90a5f7a1
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY338f3317-96c0-4b8a-8299-8ce2a10911ae1
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY1521109d-8386-472f-9483-f1fe9f7ed1521
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYef8fc378-7fee-4d20-81ec-31211e34dc6e1
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
69584-092-1069584009210100 TABLET in 1 BOTTLE (69584-092-10) 100 tablet2020-07-270000-00-00NoNoCurrent
69584-092-5069584009250500 TABLET in 1 BOTTLE (69584-092-50) 500 tablet2020-07-270000-00-00NoNoCurrent