FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
64380-743
11-digit product format
643800743
Labeler code
64380
Product ID
64380-743_8b51cc64-78c9-4457-a523-161bc2049bdf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA202330
Marketing category
ANDA
Marketing start
2015-06-30
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
15 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 HYDROCHLORIDE15 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
64380-743-03Buspirone Hydrochloride60 in 1 BOTTLETABLET6015
64380-743-06Buspirone Hydrochloride100 in 1 BOTTLETABLET10015
64380-743-18Buspirone Hydrochloride180 in 1 BOTTLETABLET18015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-743-03EA - Each64380-743d7206c6a-614f-4caf-b3b4-4478151cf37212014-12-01
64380-743-18EA - Each64380-743985da327-77fd-4e9a-8423-1fe54c72211012014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]5
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]5
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBUSPIRONE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]5
WATERINACTIVE INGREDIENT059QF0KO0RBUSPIRONE HYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-743BUSPIRONE HYDROCHLORIDE TABLET [STRIDES PHARMA SCIENCE LIMITED]14Current NDC, Legacy NDC, 3 package rows20250311_cff9f09a-1ea2-4968-b57b-e62bebaae238.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSNcff9f09a-1ea2-4968-b57b-e62bebaae23815
866018busPIRone HCl 15 MG Oral TabletPSNcff9f09a-1ea2-4968-b57b-e62bebaae23815
866090busPIRone HCl 30 MG Oral TabletPSNcff9f09a-1ea2-4968-b57b-e62bebaae23815
866094busPIRone HCl 5 MG Oral TabletPSNcff9f09a-1ea2-4968-b57b-e62bebaae23815
866111busPIRone HCl 7.5 MG Oral TabletPSNcff9f09a-1ea2-4968-b57b-e62bebaae23815
866083buspirone hydrochloride 10 MG Oral TabletSCDcff9f09a-1ea2-4968-b57b-e62bebaae23815
866018buspirone hydrochloride 15 MG Oral TabletSCDcff9f09a-1ea2-4968-b57b-e62bebaae23815
866090buspirone hydrochloride 30 MG Oral TabletSCDcff9f09a-1ea2-4968-b57b-e62bebaae23815
866094buspirone hydrochloride 5 MG Oral TabletSCDcff9f09a-1ea2-4968-b57b-e62bebaae23815
866111buspirone hydrochloride 7.5 MG Oral TabletSCDcff9f09a-1ea2-4968-b57b-e62bebaae23815
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYcff9f09a-1ea2-4968-b57b-e62bebaae23815
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSYcff9f09a-1ea2-4968-b57b-e62bebaae23815
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYcff9f09a-1ea2-4968-b57b-e62bebaae23815
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSYcff9f09a-1ea2-4968-b57b-e62bebaae23815
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSYcff9f09a-1ea2-4968-b57b-e62bebaae23815

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-743-036438007430360 TABLET in 1 BOTTLE (64380-743-03) 60 tablet2015-06-300000-00-00NoNoCurrent
64380-743-0664380074306100 TABLET in 1 BOTTLE (64380-743-06) 100 tablet2015-06-300000-00-00NoNoCurrent
64380-743-1864380074318180 TABLET in 1 BOTTLE (64380-743-18) 180 tablet2015-06-300000-00-00NoNoCurrent