FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
24689-781
11-digit product format
246890781
Labeler code
24689
Product ID
24689-781_19f3df29-51b2-7f8b-e063-6294a90a542f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
APNAR PHARMA LP
Application
ANDA209696
Marketing category
ANDA
Marketing start
2024-06-17
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
5 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 HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866018, 866083, 866090, 866094, 866111

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
24689-781-01Buspirone Hydrochloride100 in 1 BOTTLETABLET1008
24689-781-05Buspirone Hydrochloride500 in 1 BOTTLETABLET5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24689-781-01EA - Each24689-78194da3e24-c1c9-4f4c-88c7-47827433d87212018-10-11
24689-781-05EA - Each24689-78189c3658a-14df-4780-be91-cffb51dd1ef812018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24689-781BUSPIRONE HYDROCHLORIDE TABLET [APNAR PHARMA LP]8Current NDC, Legacy NDC, 2 package rows20240618_3c115eea-9dbc-4e2c-9d79-42e3388fde5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN3c115eea-9dbc-4e2c-9d79-42e3388fde5a8
866018busPIRone HCl 15 MG Oral TabletPSN3c115eea-9dbc-4e2c-9d79-42e3388fde5a8
866090busPIRone HCl 30 MG Oral TabletPSN3c115eea-9dbc-4e2c-9d79-42e3388fde5a8
866094busPIRone HCl 5 MG Oral TabletPSN3c115eea-9dbc-4e2c-9d79-42e3388fde5a8
866111busPIRone HCl 7.5 MG Oral TabletPSN3c115eea-9dbc-4e2c-9d79-42e3388fde5a8
866083buspirone hydrochloride 10 MG Oral TabletSCD3c115eea-9dbc-4e2c-9d79-42e3388fde5a8
866018buspirone hydrochloride 15 MG Oral TabletSCD3c115eea-9dbc-4e2c-9d79-42e3388fde5a8
866090buspirone hydrochloride 30 MG Oral TabletSCD3c115eea-9dbc-4e2c-9d79-42e3388fde5a8
866094buspirone hydrochloride 5 MG Oral TabletSCD3c115eea-9dbc-4e2c-9d79-42e3388fde5a8
866111buspirone hydrochloride 7.5 MG Oral TabletSCD3c115eea-9dbc-4e2c-9d79-42e3388fde5a8
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY3c115eea-9dbc-4e2c-9d79-42e3388fde5a8
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSY3c115eea-9dbc-4e2c-9d79-42e3388fde5a8
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY3c115eea-9dbc-4e2c-9d79-42e3388fde5a8
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY3c115eea-9dbc-4e2c-9d79-42e3388fde5a8
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY3c115eea-9dbc-4e2c-9d79-42e3388fde5a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24689-781-0124689078101100 TABLET in 1 BOTTLE (24689-781-01) 100 tablet2024-06-170000-00-00NoNoCurrent
24689-781-0524689078105500 TABLET in 1 BOTTLE (24689-781-05) 500 tablet2024-06-170000-00-00NoNoCurrent