FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
70518-3279
11-digit product format
705183279
Labeler code
70518
Product ID
70518-3279_4ee0757f-6beb-b16e-e063-6394a90a65bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA210907
Marketing category
ANDA
Marketing start
2021-11-30
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866083

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
70518-3279-0Buspirone Hydrochloride30 in 1 BLISTER PACKTABLET307
70518-3279-1Buspirone Hydrochloride30 in 1 BLISTER PACKTABLET307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3279BUSPIRONE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]4Current NDC, Legacy NDC, 2 package rows20240316_6c6db7a9-a728-406a-81af-edd89e1cc26f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN6c6db7a9-a728-406a-81af-edd89e1cc26f7
866083buspirone hydrochloride 10 MG Oral TabletSCD6c6db7a9-a728-406a-81af-edd89e1cc26f7
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY6c6db7a9-a728-406a-81af-edd89e1cc26f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3279-07051832790030 TABLET in 1 BLISTER PACK (70518-3279-0) 30 tablet2021-11-300000-00-00NoNoCurrent
70518-3279-17051832790130 TABLET in 1 BLISTER PACK (70518-3279-1) 30 tablet2025-07-31NoNoCurrent