FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
33261-015
11-digit product format
332610015
Labeler code
33261
Product ID
33261-015_33365e8c-5579-4254-aac1-04601d46cec7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA075022
Marketing category
ANDA
Marketing start
2002-03-01
Marketing end
0000-00-00
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
15 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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
33261-015-302020-01-31C16284748780-19d75b9d0-8839-f424-e053-dadaa90a57ceBusPIRone HYDROCHLORIDE TABLETS USP 0053 0054 1003 5200 Rx only
33261-015-602020-01-31C16284748780-19d75b9d0-8839-f424-e053-dadaa90a57ceBusPIRone HYDROCHLORIDE TABLETS USP 0053 0054 1003 5200 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-015-30Buspirone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET302
33261-015-60Buspirone Hydrochloride60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-015-30EA - Each33261-0154521d59a-987e-42a8-ae00-009217d4a90f12015-10-02
33261-015-60EA - Each33261-0150d02d487-2e49-40d2-adf8-9b866a39509812015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUSPIRONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-015BUSPIRONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2Legacy NDC, 2 package rows20120913_7edf55c5-1388-4542-a8a5-2a6187afffbd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN7edf55c5-1388-4542-a8a5-2a6187afffbd2
866018busPIRone HCl 15 MG Oral TabletPSN7edf55c5-1388-4542-a8a5-2a6187afffbd2
866083buspirone hydrochloride 10 MG Oral TabletSCD7edf55c5-1388-4542-a8a5-2a6187afffbd2
866018buspirone hydrochloride 15 MG Oral TabletSCD7edf55c5-1388-4542-a8a5-2a6187afffbd2
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY7edf55c5-1388-4542-a8a5-2a6187afffbd2
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY7edf55c5-1388-4542-a8a5-2a6187afffbd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-015-303326100153030 in 1 BOTTLE, PLASTICHistorical
33261-015-603326100156060 in 1 BOTTLEHistorical