Buspirone Hydrochloride

Product NDC
70518-4443
11-digit product format
705184443
Labeler code
70518
Product ID
70518-4443_3c561aae-b9a9-7ad2-e063-6294a90a8300
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA075388
Marketing category
ANDA
Marketing start
2025-08-14
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
10 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 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
70518-4443-0Buspirone Hydrochloride30 in 1 BLISTER PACKTABLET301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSNef8fc378-7fee-4d20-81ec-31211e34dc6e1
866083buspirone hydrochloride 10 MG Oral TabletSCDef8fc378-7fee-4d20-81ec-31211e34dc6e1
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYef8fc378-7fee-4d20-81ec-31211e34dc6e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4443-07051844430030 TABLET in 1 BLISTER PACK (70518-4443-0) 30 tablet2025-08-14NoNoHistorical