FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
70518-4052
11-digit product format
705184052
Labeler code
70518
Product ID
70518-4052_44ac71c4-0d57-7cc2-e063-6294a90abb89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA210907
Marketing category
ANDA
Marketing start
2024-04-15
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
70518-4052-0Buspirone Hydrochloride30 in 1 BLISTER PACKTABLET306
70518-4052-1Buspirone Hydrochloride60 in 1 BOTTLE, PLASTICTABLET606
70518-4052-2Buspirone Hydrochloride30 in 1 BLISTER PACKTABLET306
70518-4052-3Buspirone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET906
70518-4052-4Buspirone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4052BUSPIRONE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]3Current NDC, 5 package rows20250215_fbff8248-b73c-474e-907e-449f8316c629.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866018busPIRone HCl 15 MG Oral TabletPSNfbff8248-b73c-474e-907e-449f8316c6296
866018buspirone hydrochloride 15 MG Oral TabletSCDfbff8248-b73c-474e-907e-449f8316c6296
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYfbff8248-b73c-474e-907e-449f8316c6296

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4052-07051840520030 TABLET in 1 BLISTER PACK (70518-4052-0) 30 tablet2024-04-15NoNoCurrent
70518-4052-17051840520160 in 1 BOTTLE, PLASTICHistorical
70518-4052-27051840520230 TABLET in 1 BLISTER PACK (70518-4052-2) 30 tablet2025-02-12NoNoCurrent
70518-4052-37051840520390 TABLET in 1 BOTTLE, PLASTIC (70518-4052-3) 90 tablet2025-06-18NoNoCurrent
70518-4052-47051840520430 TABLET in 1 BOTTLE, PLASTIC (70518-4052-4) 30 tablet2025-11-28NoNoCurrent