Buspirone Hydrochloride

Product NDC
68071-2987
11-digit product format
680712987
Labeler code
68071
Product ID
68071-2987_2dcdccf6-bd84-0ce9-e063-6394a90a0c0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA210907
Marketing category
ANDA
Marketing start
2019-11-14
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2987-32025-02-10C16284748780-12cef2736-7e12-d83d-e063-dadaa90ab31fBuspirone Hydrochloride Tablets, USP Rx Only
68071-2987-32025-01-30C16284748780-12cef2736-7e12-d83d-e063-dadaa90ab31fBuspirone Hydrochloride Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2987-3Buspirone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2987BUSPIRONE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 1 package rows20250212_f98d258d-6479-253a-e053-6394a90acbb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866018busPIRone HCl 15 MG Oral TabletPSNf98d258d-6479-253a-e053-6394a90acbb32
866018buspirone hydrochloride 15 MG Oral TabletSCDf98d258d-6479-253a-e053-6394a90acbb32
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYf98d258d-6479-253a-e053-6394a90acbb32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-2987-36807129870330 TABLET in 1 BOTTLE, PLASTIC (68071-2987-3) 30 tablet2023-04-17NoNoCurrent