Buspirone hydrochloride

Product NDC
50268-135
11-digit product format
502680135
Labeler code
50268
Product ID
50268-135_4c3657a8-f6bd-b2a4-e063-6394a90a741d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA078888
Marketing category
ANDA
Marketing start
2020-10-21
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
15 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Buspirone hydrochloride
Listing expiration
2027-12-31

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
50268-135-11Buspirone hydrochloride1 in 1 BLISTER PACKTABLET16
50268-135-15Buspirone hydrochloride50 in 1 BOXTABLET506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-135BUSPIRONE HYDROCHLORIDE TABLET [AVPAK]4Current NDC, Legacy NDC, 2 package rows20240110_b230197c-3d50-7874-e053-2a95a90af50f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866018busPIRone HCl 15 MG Oral TabletPSNb230197c-3d50-7874-e053-2a95a90af50f6
866018buspirone hydrochloride 15 MG Oral TabletSCDb230197c-3d50-7874-e053-2a95a90af50f6
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYb230197c-3d50-7874-e053-2a95a90af50f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-135-11502680135111 in 1 BLISTER PACKHistorical
50268-135-155026801351550 BLISTER PACK in 1 BOX (50268-135-15) / 1 TABLET in 1 BLISTER PACK (50268-135-11) 50 blister pack2020-10-210000-00-00NoNoCurrent