Buspirone hydrochloride

Product NDC
70518-3906
11-digit product format
705183906
Labeler code
70518
Product ID
70518-3906_3f8e5042-7595-3d55-e063-6294a90a4e4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078888
Marketing category
ANDA
Marketing start
2023-11-03
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
70518-3906-0Buspirone hydrochloride30 in 1 BLISTER PACKTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3906BUSPIRONE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]2Current NDC, 1 package rows20240404_fa3f9c0e-261d-4ceb-8cc7-e5e013563479.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866111busPIRone HCl 7.5 MG Oral TabletPSNfa3f9c0e-261d-4ceb-8cc7-e5e0135634793
866111buspirone hydrochloride 7.5 MG Oral TabletSCDfa3f9c0e-261d-4ceb-8cc7-e5e0135634793
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSYfa3f9c0e-261d-4ceb-8cc7-e5e0135634793

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3906-07051839060030 TABLET in 1 BLISTER PACK (70518-3906-0) 30 tablet2023-11-03NoNoHistorical