Buspirone Hydrochloride

Product NDC
68071-3834
11-digit product format
680713834
Labeler code
68071
Product ID
68071-3834_335107d2-e2ba-835d-e063-6394a90a9142
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA210907
Marketing category
ANDA
Marketing start
2023-10-17
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
15 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 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
68071-3834-3Buspirone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3834BUSPIRONE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20250423_335107c9-5799-c4df-e063-6294a90a5ca0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866018busPIRone HCl 15 MG Oral TabletPSN335107c9-5799-c4df-e063-6294a90a5ca01
866018buspirone hydrochloride 15 MG Oral TabletSCD335107c9-5799-c4df-e063-6294a90a5ca01
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY335107c9-5799-c4df-e063-6294a90a5ca01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3834-36807138340330 TABLET in 1 BOTTLE, PLASTIC (68071-3834-3) 30 tablet2025-04-21NoNoCurrent