FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
71335-1752
11-digit product format
713351752
Labeler code
71335
Product ID
71335-1752_2c5bc398-196c-486c-869e-0f323ca0272f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075388
Marketing category
ANDA
Marketing start
2020-07-27
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

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
71335-1752-1Buspirone Hydrochloride30 in 1 BOTTLETABLET30104
71335-1752-2Buspirone Hydrochloride100 in 1 BOTTLETABLET100104
71335-1752-3Buspirone Hydrochloride60 in 1 BOTTLETABLET60104
71335-1752-4Buspirone Hydrochloride90 in 1 BOTTLETABLET90104
71335-1752-5Buspirone Hydrochloride120 in 1 BOTTLETABLET120104
71335-1752-6Buspirone Hydrochloride28 in 1 BOTTLETABLET28104
71335-1752-7Buspirone Hydrochloride180 in 1 BOTTLETABLET180104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1752-1EA - Each71335-17526c2cbf5e-af9a-4ea6-ad63-e9fba6fafef512023-12-05
71335-1752-3EA - Each71335-1752bfba71b4-4261-4ce1-8057-b8fd4d1ed3f912023-12-05
71335-1752-4EA - Each71335-175287a4ab9b-e154-4464-8cd6-db199048485d12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1752BUSPIRONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 7 package rows20240502_f85b59b7-b945-4440-8378-987bd287a655.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866018busPIRone HCl 15 MG Oral TabletPSNf85b59b7-b945-4440-8378-987bd287a655104
866018buspirone hydrochloride 15 MG Oral TabletSCDf85b59b7-b945-4440-8378-987bd287a655104
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYf85b59b7-b945-4440-8378-987bd287a655104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1752-17133517520130 TABLET in 1 BOTTLE (71335-1752-1) 30 tablet2021-04-220000-00-00NoNoCurrent
71335-1752-271335175202100 TABLET in 1 BOTTLE (71335-1752-2) 100 tablet2020-12-310000-00-00NoNoCurrent
71335-1752-37133517520360 TABLET in 1 BOTTLE (71335-1752-3) 60 tablet2021-02-040000-00-00NoNoCurrent
71335-1752-47133517520490 TABLET in 1 BOTTLE (71335-1752-4) 90 tablet2021-04-120000-00-00NoNoCurrent
71335-1752-571335175205120 TABLET in 1 BOTTLE (71335-1752-5) 120 tablet2021-12-100000-00-00NoNoCurrent
71335-1752-67133517520628 TABLET in 1 BOTTLE (71335-1752-6) 28 tablet2022-05-030000-00-00NoNoCurrent
71335-1752-771335175207180 TABLET in 1 BOTTLE (71335-1752-7) 180 tablet2022-03-010000-00-00NoNoCurrent