FDA.reportPublic FDA data

BUSPIRONE HYDROCHLORIDE

Product NDC
61919-579
11-digit product format
619190579
Labeler code
61919
Product ID
61919-579_ae5a138a-bcb4-08dd-e053-2a95a90a0478
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUSPIRONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Direct Rx
Application
ANDA075022
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
15 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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
61919-579-302025-01-30C16284748780-12cef2736-ae11-d83d-e063-dadaa90ab31fBUSPIRONE HYDROCHLORIDE
61919-579-602025-01-30C16284748780-12cef2736-ae11-d83d-e063-dadaa90ab31fBUSPIRONE HYDROCHLORIDE
61919-579-722025-01-30C16284748780-12cef2736-ae11-d83d-e063-dadaa90ab31fBUSPIRONE HYDROCHLORIDE
61919-579-902025-01-30C16284748780-12cef2736-ae11-d83d-e063-dadaa90ab31fBUSPIRONE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-579-30BUSPIRONE HYDROCHLORIDE30 in 1 BOTTLETABLET306
61919-579-60BUSPIRONE HYDROCHLORIDE60 in 1 BOTTLETABLET606
61919-579-72BUSPIRONE HYDROCHLORIDE120 in 1 BOTTLETABLET1206
61919-579-90BUSPIRONE HYDROCHLORIDE90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-579-30EA - Each61919-579f546455f-080c-4e18-af79-c45a1db818a712014-06-03
61919-579-60EA - Each61919-5795f1a59b0-282d-4f08-a255-84297b5db02812020-07-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [DIRECT RX]1
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [DIRECT RX]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUSPIRONE HYDROCHLORIDE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-579BUSPIRONE HYDROCHLORIDE TABLET [DIRECT RX]6Legacy NDC, 4 package rows20230509_1cbe2bbe-56e3-4904-93d9-d9c3c0daa165.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866018busPIRone HCl 15 MG Oral TabletPSN1cbe2bbe-56e3-4904-93d9-d9c3c0daa1656
866018buspirone hydrochloride 15 MG Oral TabletSCD1cbe2bbe-56e3-4904-93d9-d9c3c0daa1656
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY1cbe2bbe-56e3-4904-93d9-d9c3c0daa1656

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-579-306191905793030 TABLET in 1 BOTTLE (61919-579-30) 30 tablet2014-01-010000-00-00NoNoCurrent
61919-579-606191905796060 TABLET in 1 BOTTLE (61919-579-60) 60 tablet2014-01-010000-00-00NoNoCurrent
61919-579-7261919057972120 TABLET in 1 BOTTLE (61919-579-72) 120 tablet2014-01-010000-00-00NoNoCurrent
61919-579-906191905799090 TABLET in 1 BOTTLE (61919-579-90) 90 tablet2014-01-010000-00-00NoNoCurrent