FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
64380-741
11-digit product format
643800741
Labeler code
64380
Product ID
64380-741_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
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, 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
64380-741-06Buspirone Hydrochloride100 in 1 BOTTLETABLET10015
64380-741-07Buspirone Hydrochloride500 in 1 BOTTLETABLET50015
64380-741-08Buspirone Hydrochloride1000 in 1 BOTTLETABLET100015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-741-06EA - Each64380-7419cfc2199-8bf2-475d-af71-786e03aafc6012014-12-01
64380-741-07EA - Each64380-7410b0b55cc-a5e6-4293-87c1-9e8fd81ccc7b12015-07-20
64380-741-08EA - Each64380-7414b8265b9-bad5-476b-ae24-dac468e4ae4a12015-07-20

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
64380-741BUSPIRONE 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
866094busPIRone HCl 5 MG Oral TabletPSNb42cc365-6259-4d2e-9648-d37718b65e1e13
866094buspirone hydrochloride 5 MG Oral TabletSCDb42cc365-6259-4d2e-9648-d37718b65e1e13
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSYb42cc365-6259-4d2e-9648-d37718b65e1e13
866094busPIRone HCl 5 MG Oral TabletPSN24a95296-5fbe-49df-b1fe-4760d3a5ffe12
866094busPIRone HCl 5 MG Oral TabletPSN1790d63d-ecb1-da9d-e063-6294a90a50ba2
866094buspirone hydrochloride 5 MG Oral TabletSCD24a95296-5fbe-49df-b1fe-4760d3a5ffe12
866094buspirone hydrochloride 5 MG Oral TabletSCD1790d63d-ecb1-da9d-e063-6294a90a50ba2
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY24a95296-5fbe-49df-b1fe-4760d3a5ffe12
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY1790d63d-ecb1-da9d-e063-6294a90a50ba2
866094busPIRone HCl 5 MG Oral TabletPSN94874520-e286-4e2d-87a6-f600b0f96f091
866094buspirone hydrochloride 5 MG Oral TabletSCD94874520-e286-4e2d-87a6-f600b0f96f091
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY94874520-e286-4e2d-87a6-f600b0f96f091

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-741-0664380074106100 TABLET in 1 BOTTLE (64380-741-06) 100 tablet2015-06-300000-00-00NoNoCurrent
64380-741-0764380074107500 TABLET in 1 BOTTLE (64380-741-07) 500 tablet2015-06-300000-00-00NoNoCurrent
64380-741-08643800741081000 TABLET in 1 BOTTLE (64380-741-08) 1000 tablet2015-06-300000-00-00NoNoCurrent