Buspirone Hydrochloride

Product NDC
71335-1938
11-digit product format
713351938
Labeler code
71335
Product ID
71335-1938_459d57f6-0b83-43b4-8cdd-921fa72a2818
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
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
Rxcui866094

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
71335-1938-1Buspirone Hydrochloride90 in 1 BOTTLETABLET90104
71335-1938-2Buspirone Hydrochloride45 in 1 BOTTLETABLET45104
71335-1938-3Buspirone Hydrochloride30 in 1 BOTTLETABLET30104
71335-1938-4Buspirone Hydrochloride60 in 1 BOTTLETABLET60104
71335-1938-5Buspirone Hydrochloride180 in 1 BOTTLETABLET180104
71335-1938-6Buspirone Hydrochloride120 in 1 BOTTLETABLET120104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1938BUSPIRONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 6 package rows20240415_2df0b238-14a4-40ca-a235-411f6c9b8338.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866094busPIRone HCl 5 MG Oral TabletPSN2df0b238-14a4-40ca-a235-411f6c9b8338104
866094buspirone hydrochloride 5 MG Oral TabletSCD2df0b238-14a4-40ca-a235-411f6c9b8338104
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY2df0b238-14a4-40ca-a235-411f6c9b8338104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1938-17133519380190 TABLET in 1 BOTTLE (71335-1938-1) 90 tablet2021-10-270000-00-00NoNoCurrent
71335-1938-27133519380245 TABLET in 1 BOTTLE (71335-1938-2) 45 tablet2024-04-080000-00-00NoNoCurrent
71335-1938-37133519380330 TABLET in 1 BOTTLE (71335-1938-3) 30 tablet2022-06-030000-00-00NoNoCurrent
71335-1938-47133519380460 TABLET in 1 BOTTLE (71335-1938-4) 60 tablet2022-09-260000-00-00NoNoCurrent
71335-1938-571335193805180 TABLET in 1 BOTTLE (71335-1938-5) 180 tablet2024-04-080000-00-00NoNoCurrent
71335-1938-671335193806120 TABLET in 1 BOTTLE (71335-1938-6) 120 tablet2024-04-080000-00-00NoNoCurrent