FDA.reportPublic FDA data

BUSPIRONE HYDROCHLORIDE

Product NDC
61919-600
11-digit product format
619190600
Labeler code
61919
Product ID
61919-600_73b417dc-de07-4e3b-8d6f-bb4cad514b91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUSPIRONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
DirectRX
Application
ANDA078888
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
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
61919-600-902020-01-31C16284748780-19d75b9d0-4e3d-f424-e053-dadaa90a57ceBUSPIRONE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-600-90BUSPIRONE HYDROCHLORIDE90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-600-90EA - Each61919-6003a86da94-fe54-4dfd-a119-f448ba1e0ac112018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [DIRECTRX]1
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [DIRECTRX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [DIRECTRX]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [DIRECTRX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBUSPIRONE HYDROCHLORIDE TABLET [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [DIRECTRX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-600BUSPIRONE HYDROCHLORIDE TABLET [DIRECTRX]1Legacy NDC, 1 package rows20151029_a0aa6344-3a88-4726-b621-7fb3b930be3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSNa0aa6344-3a88-4726-b621-7fb3b930be3e1
866083buspirone hydrochloride 10 MG Oral TabletSCDa0aa6344-3a88-4726-b621-7fb3b930be3e1
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYa0aa6344-3a88-4726-b621-7fb3b930be3e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-600-906191906009090 in 1 BOTTLEHistorical