Buspirone Hydrochloride

Product NDC
53002-1017
11-digit product format
530021017
Labeler code
53002
Product ID
53002-1017_309352d9-0436-40d6-ae20-a051cfe85acc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA075022
Marketing category
ANDA
Marketing start
2002-02-28
Marketing end
0000-00-00
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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
53002-1017-02025-01-30C16284748780-19d75b9d0-c703-f424-e053-dadaa90a57ceBusPIRone Hydrochloride Tablets USP Rx only
53002-1017-32025-01-30C16284748780-19d75b9d0-c703-f424-e053-dadaa90a57ceBusPIRone Hydrochloride Tablets USP Rx only
53002-1017-62025-01-30C16284748780-19d75b9d0-c703-f424-e053-dadaa90a57ceBusPIRone Hydrochloride Tablets USP Rx only
53002-1017-02023-06-07C16284748780-19d75b9d0-c703-f424-e053-dadaa90a57ceBusPIRone Hydrochloride Tablets USP Rx only
53002-1017-32023-06-07C16284748780-19d75b9d0-c703-f424-e053-dadaa90a57ceBusPIRone Hydrochloride Tablets USP Rx only
53002-1017-62023-06-07C16284748780-19d75b9d0-c703-f424-e053-dadaa90a57ceBusPIRone Hydrochloride Tablets USP Rx only
53002-1017-02023-01-30C16284748780-19d75b9d0-c703-f424-e053-dadaa90a57ceBusPIRone Hydrochloride Tablets USP Rx only
53002-1017-32023-01-30C16284748780-19d75b9d0-c703-f424-e053-dadaa90a57ceBusPIRone Hydrochloride Tablets USP Rx only
53002-1017-62023-01-30C16284748780-19d75b9d0-c703-f424-e053-dadaa90a57ceBusPIRone Hydrochloride Tablets USP Rx only
53002-1017-02020-12-15C16284748780-19d75b9d0-c703-f424-e053-dadaa90a57ceBusPIRone Hydrochloride Tablets USP Rx only
53002-1017-32020-12-15C16284748780-19d75b9d0-c703-f424-e053-dadaa90a57ceBusPIRone Hydrochloride Tablets USP Rx only
53002-1017-62020-12-15C16284748780-19d75b9d0-c703-f424-e053-dadaa90a57ceBusPIRone Hydrochloride Tablets USP Rx only
53002-1017-02020-01-31C16284748780-19d75b9d0-c703-f424-e053-dadaa90a57ceBusPIRone Hydrochloride Tablets USP Rx only
53002-1017-32020-01-31C16284748780-19d75b9d0-c703-f424-e053-dadaa90a57ceBusPIRone Hydrochloride Tablets USP Rx only
53002-1017-62020-01-31C16284748780-19d75b9d0-c703-f424-e053-dadaa90a57ceBusPIRone Hydrochloride Tablets USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-1017-0Buspirone Hydrochloride100 in 1 BOTTLETABLET1005
53002-1017-3Buspirone Hydrochloride30 in 1 BOTTLETABLET305
53002-1017-6Buspirone Hydrochloride60 in 1 BOTTLETABLET605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1017BUSPIRONE HYDROCHLORIDE TABLET [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 3 package rows20230609_20e3c81a-ff4f-4691-bf1a-a4e522e7a56f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN20e3c81a-ff4f-4691-bf1a-a4e522e7a56f5
866083buspirone hydrochloride 10 MG Oral TabletSCD20e3c81a-ff4f-4691-bf1a-a4e522e7a56f5
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY20e3c81a-ff4f-4691-bf1a-a4e522e7a56f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-1017-053002101700100 TABLET in 1 BOTTLE (53002-1017-0) 100 tablet2017-09-010000-00-00NoNoCurrent
53002-1017-35300210170330 TABLET in 1 BOTTLE (53002-1017-3) 30 tablet2017-09-010000-00-00NoNoCurrent
53002-1017-65300210170660 TABLET in 1 BOTTLE (53002-1017-6) 60 tablet2017-09-010000-00-00NoNoCurrent