FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
83209-303
11-digit product format
832090303
Labeler code
83209
Product ID
83209-303_438f5c4d-a00a-b851-e063-6394a90a084a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Boswell Pharmacy Services LLC d/b/a BPS Wholesale
Application
ANDA075022
Marketing category
ANDA
Marketing start
2025-11-13
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
83209-303-15Buspirone Hydrochloride15 in 1 BLISTER PACKTABLET151
83209-303-20Buspirone Hydrochloride20 in 1 BLISTER PACKTABLET201
83209-303-30Buspirone Hydrochloride30 in 1 BLISTER PACKTABLET301
83209-303-60Buspirone Hydrochloride60 in 1 BLISTER PACKTABLET601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866018busPIRone HCl 15 MG Oral TabletPSN438f5c4d-a009-b851-e063-6394a90a084a1
866018buspirone hydrochloride 15 MG Oral TabletSCD438f5c4d-a009-b851-e063-6394a90a084a1
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY438f5c4d-a009-b851-e063-6394a90a084a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83209-303-158320903031515 TABLET in 1 BLISTER PACK (83209-303-15) 15 tablet2025-11-13NoNoCurrent
83209-303-208320903032020 TABLET in 1 BLISTER PACK (83209-303-20) 20 tablet2025-11-13NoNoCurrent
83209-303-308320903033030 TABLET in 1 BLISTER PACK (83209-303-30) 30 tablet2025-11-13NoNoCurrent
83209-303-608320903036060 TABLET in 1 BLISTER PACK (83209-303-60) 60 tablet2025-11-13NoNoCurrent