Buspirone Hydrochloride

Product NDC
70518-4068
11-digit product format
705184068
Labeler code
70518
Product ID
70518-4068_3fa2e69e-0c7d-9409-e063-6394a90a7ccc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA210907
Marketing category
ANDA
Marketing start
2024-05-05
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
30 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 HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866090

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
70518-4068-0Buspirone Hydrochloride30 in 1 BLISTER PACKTABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4068BUSPIRONE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]1Current NDC, 1 package rows20240507_ed2b56fe-e02f-46bc-808a-352f9bbb5b57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866090busPIRone HCl 30 MG Oral TabletPSNed2b56fe-e02f-46bc-808a-352f9bbb5b572
866090buspirone hydrochloride 30 MG Oral TabletSCDed2b56fe-e02f-46bc-808a-352f9bbb5b572
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSYed2b56fe-e02f-46bc-808a-352f9bbb5b572

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4068-07051840680030 TABLET in 1 BLISTER PACK (70518-4068-0) 30 tablet2024-05-05NoNoCurrent