FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
50090-7293
11-digit product format
500907293
Labeler code
50090
Product ID
50090-7293_dc79dd0b-dceb-4f47-917a-7763da9df877
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
15 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Buspirone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUSPIRONE HYDROCHLORIDE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866018

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
50090-7293-0Buspirone Hydrochloride180 in 1 BOTTLETABLET1804
50090-7293-1Buspirone Hydrochloride60 in 1 BOTTLETABLET604
50090-7293-3Buspirone Hydrochloride90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7293-0EA - Each50090-7293896b45ff-23f9-491f-b86a-e93d26fb36e412024-11-05
50090-7293-1EA - Each50090-7293f82b5eca-2a44-4051-9f10-d2e16c1012fd12024-11-05
50090-7293-3EA - Each50090-72938a6f3f78-9ff1-462e-ae98-0c7b89a511ee12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7293BUSPIRONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20241016_84621631-4c13-4147-ae3c-4ed30d4ebb37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866018busPIRone HCl 15 MG Oral TabletPSN84621631-4c13-4147-ae3c-4ed30d4ebb374
866018buspirone hydrochloride 15 MG Oral TabletSCD84621631-4c13-4147-ae3c-4ed30d4ebb374
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY84621631-4c13-4147-ae3c-4ed30d4ebb374

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7293-050090729300180 TABLET in 1 BOTTLE (50090-7293-0) 180 tablet2024-10-08NoNoHistorical
50090-7293-15009072930160 TABLET in 1 BOTTLE (50090-7293-1) 60 tablet2024-10-08NoNoHistorical
50090-7293-35009072930390 TABLET in 1 BOTTLE (50090-7293-3) 90 tablet2024-10-08NoNoHistorical