FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
51079-985
11-digit product format
510790985
Labeler code
51079
Product ID
51079-985_3a3995cf-40e7-1867-e063-6294a90aa483
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA076008
Marketing category
ANDA
Marketing start
2002-03-25
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
5 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 HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866018, 866083, 866090, 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
51079-985-01Buspirone Hydrochloride1 in 1 BLISTER PACKTABLET122
51079-985-20Buspirone Hydrochloride100 in 1 CARTONTABLET10022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-985-01EA - Each51079-985b0ab884d-3045-4607-9625-f72ef16abf9c12012-07-24
51079-985-20EA - Each51079-985adcd14f2-97cd-49fe-9802-1331e19f16dc12012-07-24

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
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]9
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]9
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUSPIRONE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]9
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JBUSPIRONE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-985BUSPIRONE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]21Current NDC, Legacy NDC, 2 package rows20231228_91bb5fc9-5121-43c2-b2af-149240d4189a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN91bb5fc9-5121-43c2-b2af-149240d4189a22
866018busPIRone HCl 15 MG Oral TabletPSN91bb5fc9-5121-43c2-b2af-149240d4189a22
866090busPIRone HCl 30 MG Oral TabletPSN91bb5fc9-5121-43c2-b2af-149240d4189a22
866094busPIRone HCl 5 MG Oral TabletPSN91bb5fc9-5121-43c2-b2af-149240d4189a22
866083buspirone hydrochloride 10 MG Oral TabletSCD91bb5fc9-5121-43c2-b2af-149240d4189a22
866018buspirone hydrochloride 15 MG Oral TabletSCD91bb5fc9-5121-43c2-b2af-149240d4189a22
866090buspirone hydrochloride 30 MG Oral TabletSCD91bb5fc9-5121-43c2-b2af-149240d4189a22
866094buspirone hydrochloride 5 MG Oral TabletSCD91bb5fc9-5121-43c2-b2af-149240d4189a22
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY91bb5fc9-5121-43c2-b2af-149240d4189a22
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY91bb5fc9-5121-43c2-b2af-149240d4189a22
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY91bb5fc9-5121-43c2-b2af-149240d4189a22
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY91bb5fc9-5121-43c2-b2af-149240d4189a22
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
51079-985-01510790985011 in 1 BLISTER PACKHistorical
51079-985-2051079098520100 BLISTER PACK in 1 CARTON (51079-985-20) / 1 TABLET in 1 BLISTER PACK (51079-985-01) 100 blister pack2002-03-250000-00-00NoNoCurrent