FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
50090-6649
11-digit product format
500906649
Labeler code
50090
Product ID
50090-6649_336dea40-3aff-479b-9a31-0282dc252709
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
Rxcui866083

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
50090-6649-0Buspirone Hydrochloride30 in 1 BOTTLETABLET303
50090-6649-1Buspirone Hydrochloride90 in 1 BOTTLETABLET903
50090-6649-3Buspirone Hydrochloride180 in 1 BOTTLETABLET1803
50090-6649-4Buspirone Hydrochloride45 in 1 BOTTLETABLET453
50090-6649-5Buspirone Hydrochloride60 in 1 BOTTLETABLET603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6649-0EA - Each50090-66492f30a643-d472-4333-a1ad-7492822d27ce12023-10-16
50090-6649-1EA - Each50090-6649cef57c55-a4c6-4950-acc1-5ed0619448b812023-10-16
50090-6649-3EA - Each50090-66492edf479a-3d7a-4100-addd-a14ad21c4b1c12023-10-16
50090-6649-4EA - Each50090-664999d7e3e9-2b71-41d7-bc96-7001251f180e12023-10-16
50090-6649-5EA - Each50090-6649083cdfba-ba71-4ec8-be73-fe97011f828c12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6649BUSPIRONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 5 package rows20230905_e4d44e49-eb8f-454e-a737-22caf30bda78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6649-05009066490030 TABLET in 1 BOTTLE (50090-6649-0) 30 tablet2023-08-30NoNoCurrent
50090-6649-15009066490190 TABLET in 1 BOTTLE (50090-6649-1) 90 tablet2023-08-30NoNoCurrent
50090-6649-350090664903180 TABLET in 1 BOTTLE (50090-6649-3) 180 tablet2023-08-30NoNoCurrent
50090-6649-45009066490445 TABLET in 1 BOTTLE (50090-6649-4) 45 tablet2023-08-30NoNoCurrent
50090-6649-55009066490560 TABLET in 1 BOTTLE (50090-6649-5) 60 tablet2023-08-30NoNoCurrent