FDA.reportPublic FDA data

Buspirone HCL

Product NDC
72189-620
11-digit product format
721890620
Labeler code
72189
Product ID
72189-620_3867133c-16d7-db4e-e063-6294a90a7549
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone HCL
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA210907
Marketing category
ANDA
Marketing start
2025-04-08
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 HCL
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
72189-620-30Buspirone HCL30 in 1 BOTTLETABLET304
72189-620-60Buspirone HCL60 in 1 BOTTLETABLET604
72189-620-90Buspirone HCL90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-620-30EA - Each72189-620854fce93-0beb-460b-8e17-dac8a9a6025712025-05-14
72189-620-60EA - Each72189-620e345d4c9-4d4f-4973-bb4f-c69667b9c6fa12025-05-14
72189-620-90EA - Each72189-62036cc9926-adc4-4983-bd22-a10192537dd412025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-620BUSPIRONE HCL TABLET [DIRECT_RX]3Current NDC, 3 package rows20250419_3246dd4d-f787-2f62-e063-6294a90a9cd2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866018busPIRone HCl 15 MG Oral TabletPSN3246dd4d-f787-2f62-e063-6294a90a9cd24
866018buspirone hydrochloride 15 MG Oral TabletSCD3246dd4d-f787-2f62-e063-6294a90a9cd24
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY3246dd4d-f787-2f62-e063-6294a90a9cd24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-620-307218906203030 TABLET in 1 BOTTLE (72189-620-30) 30 tablet2025-04-08NoNoHistorical
72189-620-607218906206060 TABLET in 1 BOTTLE (72189-620-60) 60 tablet2025-04-08NoNoHistorical
72189-620-907218906209090 TABLET in 1 BOTTLE (72189-620-90) 90 tablet2025-04-08NoNoHistorical