BusPIRone Hydrochloride

Product NDC
53002-5017
11-digit product format
530025017
Labeler code
53002
Product ID
53002-5017_d240572e-ddfc-4f9b-9b1b-aade3a013b15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BusPIRone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA209696
Marketing category
ANDA
Marketing start
2018-07-03
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-5017-0BusPIRone Hydrochloride100 in 1 BOTTLETABLET1001
53002-5017-3BusPIRone Hydrochloride30 in 1 BOTTLETABLET301
53002-5017-6BusPIRone Hydrochloride60 in 1 BOTTLETABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-5017BUSPIRONE HYDROCHLORIDE TABLET [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 3 package rows20201224_e32e6011-4db6-4d85-8c7f-d5c2c2474a6a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSNe32e6011-4db6-4d85-8c7f-d5c2c2474a6a1
866083buspirone hydrochloride 10 MG Oral TabletSCDe32e6011-4db6-4d85-8c7f-d5c2c2474a6a1
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYe32e6011-4db6-4d85-8c7f-d5c2c2474a6a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-5017-053002501700100 TABLET in 1 BOTTLE (53002-5017-0) 100 tablet2019-06-010000-00-00NoNoCurrent
53002-5017-35300250170330 TABLET in 1 BOTTLE (53002-5017-3) 30 tablet2019-06-010000-00-00NoNoCurrent
53002-5017-65300250170660 TABLET in 1 BOTTLE (53002-5017-6) 60 tablet2019-06-010000-00-00NoNoCurrent