FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
71335-1749
11-digit product format
713351749
Labeler code
71335
Product ID
71335-1749_6c714746-c3e1-4b5b-846a-667ffd7f08bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210907
Marketing category
ANDA
Marketing start
2019-11-14
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
30 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 HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866090

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
71335-1749-1Buspirone Hydrochloride60 in 1 BOTTLETABLET60103
71335-1749-2Buspirone Hydrochloride30 in 1 BOTTLETABLET30103
71335-1749-3Buspirone Hydrochloride56 in 1 BOTTLETABLET56103
71335-1749-4Buspirone Hydrochloride90 in 1 BOTTLETABLET90103
71335-1749-5Buspirone Hydrochloride180 in 1 BOTTLETABLET180103
71335-1749-6Buspirone Hydrochloride15 in 1 BOTTLETABLET15103
71335-1749-7Buspirone Hydrochloride120 in 1 BOTTLETABLET120103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1749-1EA - Each71335-1749a315da44-c3a8-4826-9b63-8efb194c8bd312023-12-05
71335-1749-2EA - Each71335-17495a96665a-a1a2-47ee-811d-0e0e56273f8812023-12-05
71335-1749-3EA - Each71335-174991e1d274-2ce7-4254-a234-cce8f285e2a212023-12-05
71335-1749-4EA - Each71335-1749680781a3-6760-46f1-a2a3-777fda8a027212023-12-05
71335-1749-5EA - Each71335-17494da132be-5460-44e8-99a6-268a0187db4e12022-05-04
71335-1749-6EA - Each71335-174977a5cf54-1388-4707-9cd5-35ce04bdb7fd12023-12-05
71335-1749-7EA - Each71335-17492162f4ba-e134-436f-9379-dc38dd85578512023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1749BUSPIRONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 7 package rows20240502_a2867dde-e5dd-4cc8-84d0-59240626868a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866090busPIRone HCl 30 MG Oral TabletPSNa2867dde-e5dd-4cc8-84d0-59240626868a103
866090buspirone hydrochloride 30 MG Oral TabletSCDa2867dde-e5dd-4cc8-84d0-59240626868a103
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSYa2867dde-e5dd-4cc8-84d0-59240626868a103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1749-17133517490160 TABLET in 1 BOTTLE (71335-1749-1) 60 tablet2021-08-100000-00-00NoNoCurrent
71335-1749-27133517490230 TABLET in 1 BOTTLE (71335-1749-2) 30 tablet2021-06-040000-00-00NoNoCurrent
71335-1749-37133517490356 TABLET in 1 BOTTLE (71335-1749-3) 56 tablet2021-04-120000-00-00NoNoCurrent
71335-1749-47133517490490 TABLET in 1 BOTTLE (71335-1749-4) 90 tablet2022-01-190000-00-00NoNoCurrent
71335-1749-571335174905180 TABLET in 1 BOTTLE (71335-1749-5) 180 tablet2022-01-310000-00-00NoNoCurrent
71335-1749-67133517490615 TABLET in 1 BOTTLE (71335-1749-6) 15 tablet2021-01-210000-00-00NoNoCurrent
71335-1749-771335174907120 TABLET in 1 BOTTLE (71335-1749-7) 120 tablet2021-12-100000-00-00NoNoCurrent