FDA.reportPublic FDA data

busPIRone HCl

Product NDC
72888-063
11-digit product format
728880063
Labeler code
72888
Product ID
72888-063_47c7577d-5093-5361-e063-6294a90ae76f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Advagen Pharma Ltd
Application
ANDA075521
Marketing category
ANDA
Marketing start
2021-03-16
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
7.5 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
busPIRone HCl
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUSPIRONE HYDROCHLORIDE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866018, 866083, 866090, 866094, 866111

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72888-063-01busPIRone HCl100 in 1 BOTTLETABLET1005
72888-063-05busPIRone HCl500 in 1 BOTTLETABLET5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-063-01EA - Each72888-0630914c68c-bc59-473b-91e4-8c3c637ac1b312021-07-15
72888-063-05EA - Each72888-06324ecc63a-15bb-4a79-b54d-4deeb7ee2b0112023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-063BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [ADVAGEN PHARMA LTD]4Current NDC, Legacy NDC, 2 package rows20230120_07a789a9-c9e8-4737-a56d-7d5405fe8100.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN07a789a9-c9e8-4737-a56d-7d5405fe81005
866018busPIRone HCl 15 MG Oral TabletPSN07a789a9-c9e8-4737-a56d-7d5405fe81005
866090busPIRone HCl 30 MG Oral TabletPSN07a789a9-c9e8-4737-a56d-7d5405fe81005
866094busPIRone HCl 5 MG Oral TabletPSN07a789a9-c9e8-4737-a56d-7d5405fe81005
866111busPIRone HCl 7.5 MG Oral TabletPSN07a789a9-c9e8-4737-a56d-7d5405fe81005
866083buspirone hydrochloride 10 MG Oral TabletSCD07a789a9-c9e8-4737-a56d-7d5405fe81005
866018buspirone hydrochloride 15 MG Oral TabletSCD07a789a9-c9e8-4737-a56d-7d5405fe81005
866090buspirone hydrochloride 30 MG Oral TabletSCD07a789a9-c9e8-4737-a56d-7d5405fe81005
866094buspirone hydrochloride 5 MG Oral TabletSCD07a789a9-c9e8-4737-a56d-7d5405fe81005
866111buspirone hydrochloride 7.5 MG Oral TabletSCD07a789a9-c9e8-4737-a56d-7d5405fe81005
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY07a789a9-c9e8-4737-a56d-7d5405fe81005
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSY07a789a9-c9e8-4737-a56d-7d5405fe81005
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY07a789a9-c9e8-4737-a56d-7d5405fe81005
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY07a789a9-c9e8-4737-a56d-7d5405fe81005
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY07a789a9-c9e8-4737-a56d-7d5405fe81005
866111busPIRone HCl 7.5 MG Oral TabletPSN472049d2-c4d9-5a38-e063-6294a90a5cf12
866111buspirone hydrochloride 7.5 MG Oral TabletSCD472049d2-c4d9-5a38-e063-6294a90a5cf12
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSY472049d2-c4d9-5a38-e063-6294a90a5cf12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72888-063-0172888006301100 TABLET in 1 BOTTLE (72888-063-01) 100 tablet2021-03-160000-00-00NoNoCurrent
72888-063-0572888006305500 TABLET in 1 BOTTLE (72888-063-05) 500 tablet2021-03-160000-00-00NoNoCurrent