FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
70518-2660
11-digit product format
705182660
Labeler code
70518
Product ID
70518-2660_4d7433d8-91be-3aa8-e063-6394a90aee73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204582
Marketing category
ANDA
Marketing start
2020-03-27
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
15 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Buspirone Hydrochloride
Listing expiration
2027-12-31

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
70518-2660-0Buspirone Hydrochloride30 in 1 BLISTER PACKTABLET3015
70518-2660-1Buspirone Hydrochloride60 in 1 BLISTER PACKTABLET6015
70518-2660-2Buspirone Hydrochloride30 in 1 BLISTER PACKTABLET3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2660-0EA - Each70518-266077a128f6-b88c-4d89-a1bf-520d9450bcd712026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2660BUSPIRONE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 3 package rows20250426_fd05160d-24c6-4371-8b2c-c0f78c8b468e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866018busPIRone HCl 15 MG Oral TabletPSNfd05160d-24c6-4371-8b2c-c0f78c8b468e15
866018buspirone hydrochloride 15 MG Oral TabletSCDfd05160d-24c6-4371-8b2c-c0f78c8b468e15
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYfd05160d-24c6-4371-8b2c-c0f78c8b468e15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2660-07051826600030 TABLET in 1 BLISTER PACK (70518-2660-0) 30 tablet2020-03-270000-00-00NoNoCurrent
70518-2660-17051826600160 in 1 BLISTER PACKHistorical
70518-2660-27051826600230 TABLET in 1 BLISTER PACK (70518-2660-2) 30 tablet2026-03-20NoNoCurrent