Buspirone Hydrochloride

Product NDC
68071-2995
11-digit product format
680712995
Labeler code
68071
Product ID
68071-2995_2d53e84a-506a-e4c8-e063-6294a90a3f8d
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
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 HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866094

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
68071-2995-32025-02-04C16284748780-12cef2736-b47f-d83d-e063-dadaa90ab31fBuspirone Hydrochloride Tablets, USP Rx Only
68071-2995-32025-01-30C16284748780-12cef2736-b47f-d83d-e063-dadaa90ab31fBuspirone Hydrochloride Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2995-3Buspirone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2995BUSPIRONE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 1 package rows20250206_fbd7f3fa-11f8-a319-e053-6294a90acae4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866094busPIRone HCl 5 MG Oral TabletPSNfbd7f3fa-11f8-a319-e053-6294a90acae42
866094buspirone hydrochloride 5 MG Oral TabletSCDfbd7f3fa-11f8-a319-e053-6294a90acae42
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSYfbd7f3fa-11f8-a319-e053-6294a90acae42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-2995-36807129950330 TABLET in 1 BOTTLE, PLASTIC (68071-2995-3) 30 tablet2023-05-16NoNoCurrent