FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
71335-2060
11-digit product format
713352060
Labeler code
71335
Product ID
71335-2060_96e8ca65-5865-49f0-a3b9-d1ed9da93648
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
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
71335-2060-1Buspirone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET30103
71335-2060-2Buspirone Hydrochloride100 in 1 BOTTLE, PLASTICTABLET100103
71335-2060-3Buspirone Hydrochloride60 in 1 BOTTLE, PLASTICTABLET60103
71335-2060-4Buspirone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET90103
71335-2060-5Buspirone Hydrochloride120 in 1 BOTTLE, PLASTICTABLET120103
71335-2060-6Buspirone Hydrochloride28 in 1 BOTTLE, PLASTICTABLET28103
71335-2060-7Buspirone Hydrochloride180 in 1 BOTTLE, PLASTICTABLET180103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2060BUSPIRONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 7 package rows20240420_5fa0720f-e236-4b8b-a0c0-6f48037c76b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866018busPIRone HCl 15 MG Oral TabletPSN5fa0720f-e236-4b8b-a0c0-6f48037c76b3103
866018buspirone hydrochloride 15 MG Oral TabletSCD5fa0720f-e236-4b8b-a0c0-6f48037c76b3103
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY5fa0720f-e236-4b8b-a0c0-6f48037c76b3103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2060-17133520600130 TABLET in 1 BOTTLE, PLASTIC (71335-2060-1) 30 tablet2022-03-230000-00-00NoNoCurrent
71335-2060-271335206002100 TABLET in 1 BOTTLE, PLASTIC (71335-2060-2) 100 tablet2024-04-030000-00-00NoNoCurrent
71335-2060-37133520600360 TABLET in 1 BOTTLE, PLASTIC (71335-2060-3) 60 tablet2022-03-070000-00-00NoNoCurrent
71335-2060-47133520600490 TABLET in 1 BOTTLE, PLASTIC (71335-2060-4) 90 tablet2023-02-010000-00-00NoNoCurrent
71335-2060-571335206005120 TABLET in 1 BOTTLE, PLASTIC (71335-2060-5) 120 tablet2023-02-020000-00-00NoNoCurrent
71335-2060-67133520600628 TABLET in 1 BOTTLE, PLASTIC (71335-2060-6) 28 tablet2024-04-030000-00-00NoNoCurrent
71335-2060-771335206007180 TABLET in 1 BOTTLE, PLASTIC (71335-2060-7) 180 tablet2024-04-030000-00-00NoNoCurrent