FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
80425-0303
11-digit product format
804250303
Labeler code
80425
Product ID
80425-0303_2a9c0c91-2b32-4def-e063-6294a90a58ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA210907
Marketing category
ANDA
Marketing start
2023-04-06
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
80425-0303-1Buspirone Hydrochloride30 in 1 BOTTLETABLET302
80425-0303-2Buspirone Hydrochloride60 in 1 BOTTLETABLET602
80425-0303-3Buspirone Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0303-1EA - Each80425-0303f4913649-e1ba-42f9-8427-a607b54d7ddf12023-06-06
80425-0303-2EA - Each80425-030337cb4f00-cf48-48e7-87f2-e17af97a000112023-06-06
80425-0303-3EA - Each80425-03039453aa87-69d6-4b8b-9098-5a9978f87ac712023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0303BUSPIRONE HYDROCHLORIDE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f8afd9b8-0885-2f0c-e053-6294a90a9c57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866018busPIRone HCl 15 MG Oral TabletPSNf8afd9b8-0885-2f0c-e053-6294a90a9c572
866018buspirone hydrochloride 15 MG Oral TabletSCDf8afd9b8-0885-2f0c-e053-6294a90a9c572
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYf8afd9b8-0885-2f0c-e053-6294a90a9c572

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0303-18042503030130 TABLET in 1 BOTTLE (80425-0303-1) 30 tablet2023-04-06NoNoHistorical
80425-0303-28042503030260 TABLET in 1 BOTTLE (80425-0303-2) 60 tablet2023-04-06NoNoHistorical
80425-0303-38042503030390 TABLET in 1 BOTTLE (80425-0303-3) 90 tablet2023-04-06NoNoHistorical