Buspirone Hydrochloride

Product NDC
53002-1424
11-digit product format
530021424
Labeler code
53002
Product ID
53002-1424_e6d336e8-f391-4ad3-a42d-8c095035b819
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA075022
Marketing category
ANDA
Marketing start
2002-03-01
Marketing end
0000-00-00
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
15 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
53002-1424-32025-01-30C16284748780-12cef2736-9f96-d83d-e063-dadaa90ab31fBusPIRone Hydrochloride Tablets USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-1424-3Buspirone Hydrochloride30 in 1 BOTTLETABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1424BUSPIRONE HYDROCHLORIDE TABLET [RPK PHARMACEUTICALS, INC.]4Legacy NDC, 1 package rows20220331_2496ccca-57da-4bce-8c22-1dcdd790a131.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866018busPIRone HCl 15 MG Oral TabletPSN2496ccca-57da-4bce-8c22-1dcdd790a1314
866018buspirone hydrochloride 15 MG Oral TabletSCD2496ccca-57da-4bce-8c22-1dcdd790a1314
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY2496ccca-57da-4bce-8c22-1dcdd790a1314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-1424-35300214240330 TABLET in 1 BOTTLE (53002-1424-3) 30 tablet2021-01-010000-00-00NoNoCurrent