Buspirone Hydrochloride

Product NDC
55154-5397
11-digit product format
551545397
Labeler code
55154
Product ID
55154-5397_5aefed61-968a-4f7a-b213-3b8098a8ba07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA076008
Marketing category
ANDA
Marketing start
2010-03-31
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, 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
55154-5397-0Buspirone Hydrochloride10 in 1 BAGTABLET1021
55154-5397-0Buspirone Hydrochloride1 in 1 BLISTER PACKTABLET121

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [CARDINAL HEALTH]10
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [CARDINAL HEALTH]10
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUSPIRONE HYDROCHLORIDE TABLET [CARDINAL HEALTH]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [CARDINAL HEALTH]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [CARDINAL HEALTH]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [CARDINAL HEALTH]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JBUSPIRONE HYDROCHLORIDE TABLET [CARDINAL HEALTH]10
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [CARDINAL HEALTH]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-5397BUSPIRONE HYDROCHLORIDE TABLET [CARDINAL HEALTH 107, LLC]20Current NDC, Legacy NDC, 2 package rows20241228_2acc7da1-d5b8-4404-a3c6-d51ed82cc4fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN2acc7da1-d5b8-4404-a3c6-d51ed82cc4fd21
866094busPIRone HCl 5 MG Oral TabletPSN2acc7da1-d5b8-4404-a3c6-d51ed82cc4fd21
866083buspirone hydrochloride 10 MG Oral TabletSCD2acc7da1-d5b8-4404-a3c6-d51ed82cc4fd21
866094buspirone hydrochloride 5 MG Oral TabletSCD2acc7da1-d5b8-4404-a3c6-d51ed82cc4fd21
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY2acc7da1-d5b8-4404-a3c6-d51ed82cc4fd21
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY2acc7da1-d5b8-4404-a3c6-d51ed82cc4fd21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-5397-05515453970010 BLISTER PACK in 1 BAG (55154-5397-0) / 1 TABLET in 1 BLISTER PACK10 blister pack2010-03-310000-00-00NoNoCurrent