BUSPIRONE HYDROCHLORIDE

Product NDC
70518-4317
11-digit product format
705184317
Labeler code
70518
Product ID
70518-4317_3cf8b3b5-b4d8-216c-e063-6294a90a5156
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUSPIRONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078246
Marketing category
ANDA
Marketing start
2025-03-21
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
7.5 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 HYDROCHLORIDE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866111

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
70518-4317-0BUSPIRONE HYDROCHLORIDE30 in 1 BLISTER PACKTABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4317BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE) TABLET [REMEDYREPACK INC.]1Current NDC, 1 package rows20250323_fa4d5cac-f687-4440-99d2-8bb27cf2f4ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866111busPIRone HCl 7.5 MG Oral TabletPSNfa4d5cac-f687-4440-99d2-8bb27cf2f4ed2
866111buspirone hydrochloride 7.5 MG Oral TabletSCDfa4d5cac-f687-4440-99d2-8bb27cf2f4ed2
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSYfa4d5cac-f687-4440-99d2-8bb27cf2f4ed2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4317-07051843170030 TABLET in 1 BLISTER PACK (70518-4317-0) 30 tablet2025-03-21NoNoHistorical