FDA.reportPublic FDA data

buspirone hydrochloride

Product NDC
65841-782
11-digit product format
658410782
Labeler code
65841
Product ID
65841-782_0ea86a43-52f7-4fad-acda-a4625f4280a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA078888
Marketing category
ANDA
Marketing start
2014-05-03
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
buspirone hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUSPIRONE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866018, 866083, 866090, 866094, 866111

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
65841-782-01buspirone hydrochloride100 in 1 BOTTLETABLET1009
65841-782-05buspirone hydrochloride500 in 1 BOTTLETABLET5009
65841-782-10buspirone hydrochloride1000 in 1 BOTTLETABLET10009
65841-782-30buspirone hydrochloride1 in 1 BLISTER PACKTABLET19
65841-782-77buspirone hydrochloride100 in 1 CARTONTABLET1009

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-782BUSPIRONE HYDROCHLORIDE TABLET [ZYDUS LIFESCIENCES LIMITED]8Current NDC, Legacy NDC, 5 package rows20241128_1109dd63-6492-49b1-a383-3ab3a80cd6c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN1109dd63-6492-49b1-a383-3ab3a80cd6c79
866018busPIRone HCl 15 MG Oral TabletPSN1109dd63-6492-49b1-a383-3ab3a80cd6c79
866090busPIRone HCl 30 MG Oral TabletPSN1109dd63-6492-49b1-a383-3ab3a80cd6c79
866094busPIRone HCl 5 MG Oral TabletPSN1109dd63-6492-49b1-a383-3ab3a80cd6c79
866111busPIRone HCl 7.5 MG Oral TabletPSN1109dd63-6492-49b1-a383-3ab3a80cd6c79
866083buspirone hydrochloride 10 MG Oral TabletSCD1109dd63-6492-49b1-a383-3ab3a80cd6c79
866018buspirone hydrochloride 15 MG Oral TabletSCD1109dd63-6492-49b1-a383-3ab3a80cd6c79
866090buspirone hydrochloride 30 MG Oral TabletSCD1109dd63-6492-49b1-a383-3ab3a80cd6c79
866094buspirone hydrochloride 5 MG Oral TabletSCD1109dd63-6492-49b1-a383-3ab3a80cd6c79
866111buspirone hydrochloride 7.5 MG Oral TabletSCD1109dd63-6492-49b1-a383-3ab3a80cd6c79
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY1109dd63-6492-49b1-a383-3ab3a80cd6c79
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSY1109dd63-6492-49b1-a383-3ab3a80cd6c79
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY1109dd63-6492-49b1-a383-3ab3a80cd6c79
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY1109dd63-6492-49b1-a383-3ab3a80cd6c79
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY1109dd63-6492-49b1-a383-3ab3a80cd6c79

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-782-0165841078201100 TABLET in 1 BOTTLE (65841-782-01) 100 tablet2014-05-030000-00-00NoNoCurrent
65841-782-0565841078205500 TABLET in 1 BOTTLE (65841-782-05) 500 tablet2014-05-030000-00-00NoNoCurrent
65841-782-10658410782101000 TABLET in 1 BOTTLE (65841-782-10) 1000 tablet2014-05-030000-00-00NoNoCurrent
65841-782-30658410782301 in 1 BLISTER PACKHistorical
65841-782-7765841078277100 BLISTER PACK in 1 CARTON (65841-782-77) / 1 TABLET in 1 BLISTER PACK (65841-782-30) 100 blister pack2014-05-030000-00-00NoNoCurrent