Buspirone Hydrochloride

Product NDC
0615-8527
11-digit product format
006158527
Labeler code
0615
Product ID
0615-8527_1999411b-cc4c-4dac-a2de-c3a4dacfa1d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA075022
Marketing category
ANDA
Marketing start
2004-03-26
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
0615-8527-39Buspirone Hydrochloride30 in 1 BLISTER PACKTABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8527BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]2Current NDC, 1 package rows20241004_d5fcc60d-5465-4075-948c-1aa4ff21af4c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866090busPIRone HCl 30 MG Oral TabletPSNd5fcc60d-5465-4075-948c-1aa4ff21af4c2
866090buspirone hydrochloride 30 MG Oral TabletSCDd5fcc60d-5465-4075-948c-1aa4ff21af4c2
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSYd5fcc60d-5465-4075-948c-1aa4ff21af4c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0615-8527-390061585273930 TABLET in 1 BLISTER PACK (0615-8527-39) 30 tablet2024-09-18NoNoCurrent