Buspirone hydrochloride

Product NDC
70518-0380
11-digit product format
705180380
Labeler code
70518
Product ID
70518-0380_2b4cb86d-e507-3651-e063-6394a90a8848
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078888
Marketing category
ANDA
Marketing start
2017-04-03
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
70518-0380-0Buspirone hydrochloride30 in 1 BLISTER PACKTABLET3012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0380BUSPIRONE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]12Current NDC, Legacy NDC, 1 package rows20250112_7ac98a7f-0ded-427f-899a-c3f6d1997403.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866018busPIRone HCl 15 MG Oral TabletPSN7ac98a7f-0ded-427f-899a-c3f6d199740312
866018buspirone hydrochloride 15 MG Oral TabletSCD7ac98a7f-0ded-427f-899a-c3f6d199740312
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY7ac98a7f-0ded-427f-899a-c3f6d199740312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0380-07051803800030 TABLET in 1 BLISTER PACK (70518-0380-0) 30 tablet2017-04-030000-00-00NoNoCurrent