FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
50090-5797
11-digit product format
500905797
Labeler code
50090
Product ID
50090-5797_add5814a-6a9f-4aa7-91bc-8d154876fecc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA210907
Marketing category
ANDA
Marketing start
2019-11-14
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
Rxcui866094

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
50090-5797-1Buspirone Hydrochloride60 in 1 BOTTLETABLET607
50090-5797-2Buspirone Hydrochloride90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5797-1EA - Each50090-57978fc1ba9b-a33c-4aa4-bd79-787e24432ba112024-03-12
50090-5797-2EA - Each50090-5797d74ea84f-66a4-4562-a6d1-06e805323e5a12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5797BUSPIRONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 2 package rows20241215_932422a8-b72c-4dab-b942-2ab092ed6b01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866094busPIRone HCl 5 MG Oral TabletPSN932422a8-b72c-4dab-b942-2ab092ed6b017
866094buspirone hydrochloride 5 MG Oral TabletSCD932422a8-b72c-4dab-b942-2ab092ed6b017
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY932422a8-b72c-4dab-b942-2ab092ed6b017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5797-15009057970160 TABLET in 1 BOTTLE (50090-5797-1) 60 tablet2021-10-130000-00-00NoNoCurrent
50090-5797-25009057970290 TABLET in 1 BOTTLE (50090-5797-2) 90 tablet2024-12-06NoNoCurrent