FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
50090-4862
11-digit product format
500904862
Labeler code
50090
Product ID
50090-4862_8a5c62bd-1129-4abc-8007-da97c94300f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075022
Marketing category
ANDA
Marketing start
2004-03-26
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
Rxcui866090

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4862-02023-02-07C16284748780-1f386c64a-2892-0266-e053-dadaa90a7c1aBusPIRone Hydrochloride Tablets, USP Rx only
50090-4862-02023-01-30C16284748780-1f386c64a-2892-0266-e053-dadaa90a7c1aBusPIRone Hydrochloride Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4862-0Buspirone Hydrochloride60 in 1 BOTTLETABLET609
50090-4862-1Buspirone Hydrochloride90 in 1 BOTTLETABLET909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4862-0EA - Each50090-486255c17995-fd91-4513-96b8-56c52d719d1b12024-08-12
50090-4862-1EA - Each50090-486287f2de38-6123-4d30-9e90-42e034f3510612025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4862BUSPIRONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 2 package rows20250109_4adc1750-b89e-473d-a18f-949423a2354f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866090busPIRone HCl 30 MG Oral TabletPSN4adc1750-b89e-473d-a18f-949423a2354f9
866090buspirone hydrochloride 30 MG Oral TabletSCD4adc1750-b89e-473d-a18f-949423a2354f9
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY4adc1750-b89e-473d-a18f-949423a2354f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4862-05009048620060 TABLET in 1 BOTTLE (50090-4862-0) 60 tablet2020-01-220000-00-00NoNoCurrent
50090-4862-15009048620190 TABLET in 1 BOTTLE (50090-4862-1) 90 tablet2024-01-02NoNoCurrent