FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
69584-091
11-digit product format
695840091
Labeler code
69584
Product ID
69584-091_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
5 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 HYDROCHLORIDE5 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
69584-091-10Buspirone Hydrochloride100 in 1 BOTTLETABLET1006
69584-091-50Buspirone Hydrochloride500 in 1 BOTTLETABLET5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69584-091-10EA - Each69584-091fa9890f0-74bf-49f5-8def-3483422345f312020-09-14
69584-091-50EA - Each69584-0918a157bf4-ea81-4b63-b3f3-72c2d373e2f012020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69584-091BUSPIRONE 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
866094busPIRone HCl 5 MG Oral TabletPSNed7e334a-cc4a-47b2-a4db-56495730b698105
866094buspirone hydrochloride 5 MG Oral TabletSCDed7e334a-cc4a-47b2-a4db-56495730b698105
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSYed7e334a-cc4a-47b2-a4db-56495730b698105
866094busPIRone HCl 5 MG Oral TabletPSN5d93a30e-3544-44e7-ab6a-dc9dc79d7c71104
866094busPIRone HCl 5 MG Oral TabletPSN2df0b238-14a4-40ca-a235-411f6c9b8338104
866094buspirone hydrochloride 5 MG Oral TabletSCD5d93a30e-3544-44e7-ab6a-dc9dc79d7c71104
866094buspirone hydrochloride 5 MG Oral TabletSCD2df0b238-14a4-40ca-a235-411f6c9b8338104
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY5d93a30e-3544-44e7-ab6a-dc9dc79d7c71104
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY2df0b238-14a4-40ca-a235-411f6c9b8338104
866094busPIRone HCl 5 MG Oral TabletPSNbee0edbf-3fc3-484b-9715-f13a329216ae102
866094buspirone hydrochloride 5 MG Oral TabletSCDbee0edbf-3fc3-484b-9715-f13a329216ae102
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSYbee0edbf-3fc3-484b-9715-f13a329216ae102
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
866094busPIRone HCl 5 MG Oral TabletPSN3dd7f213-afd8-67d6-e063-6294a90ac1082
866094buspirone hydrochloride 5 MG Oral TabletSCD3dd7f213-afd8-67d6-e063-6294a90ac1082
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY3dd7f213-afd8-67d6-e063-6294a90ac1082
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 TabletPSN8e0219e9-d305-4473-8229-aee0ee84caf61
866094busPIRone HCl 5 MG Oral TabletPSN7c7225a0-8237-4998-843a-bf10fa6ec65b1
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 TabletSCD8e0219e9-d305-4473-8229-aee0ee84caf61
866094buspirone hydrochloride 5 MG Oral TabletSCD7c7225a0-8237-4998-843a-bf10fa6ec65b1
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 TabletSY8e0219e9-d305-4473-8229-aee0ee84caf61
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY7c7225a0-8237-4998-843a-bf10fa6ec65b1
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
69584-091-1069584009110100 TABLET in 1 BOTTLE (69584-091-10) 100 tablet2020-07-270000-00-00NoNoCurrent
69584-091-5069584009150500 TABLET in 1 BOTTLE (69584-091-50) 500 tablet2020-07-270000-00-00NoNoCurrent