BUSPIRONE HYDROCHLORIDE

Product NDC
59651-393
11-digit product format
596510393
Labeler code
59651
Product ID
59651-393_270d4008-311a-4f5c-905e-95f14bd9f700
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUSPIRONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA078246
Marketing category
ANDA
Marketing start
2020-02-21
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
30 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 HYDROCHLORIDE30 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
59651-393-01BUSPIRONE HYDROCHLORIDE100 in 1 BOTTLETABLET1002
59651-393-05BUSPIRONE HYDROCHLORIDE500 in 1 BOTTLETABLET5002
59651-393-10BUSPIRONE HYDROCHLORIDE10 in 1 BLISTER PACKTABLET102
59651-393-10BUSPIRONE HYDROCHLORIDE10 in 1 CARTONTABLET102
59651-393-30BUSPIRONE HYDROCHLORIDE30 in 1 BOTTLETABLET302
59651-393-60BUSPIRONE HYDROCHLORIDE60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-393-60EA - Each59651-3930bcae58f-efe3-4d19-9358-e9d953e4f70d12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-393BUSPIRONE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]2Current NDC, Legacy NDC, 6 package rows20210706_05c006d2-44b9-431f-bce2-aff09c043ecb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN05c006d2-44b9-431f-bce2-aff09c043ecb2
866018busPIRone HCl 15 MG Oral TabletPSN05c006d2-44b9-431f-bce2-aff09c043ecb2
866090busPIRone HCl 30 MG Oral TabletPSN05c006d2-44b9-431f-bce2-aff09c043ecb2
866094busPIRone HCl 5 MG Oral TabletPSN05c006d2-44b9-431f-bce2-aff09c043ecb2
866111busPIRone HCl 7.5 MG Oral TabletPSN05c006d2-44b9-431f-bce2-aff09c043ecb2
866083buspirone hydrochloride 10 MG Oral TabletSCD05c006d2-44b9-431f-bce2-aff09c043ecb2
866018buspirone hydrochloride 15 MG Oral TabletSCD05c006d2-44b9-431f-bce2-aff09c043ecb2
866090buspirone hydrochloride 30 MG Oral TabletSCD05c006d2-44b9-431f-bce2-aff09c043ecb2
866094buspirone hydrochloride 5 MG Oral TabletSCD05c006d2-44b9-431f-bce2-aff09c043ecb2
866111buspirone hydrochloride 7.5 MG Oral TabletSCD05c006d2-44b9-431f-bce2-aff09c043ecb2
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY05c006d2-44b9-431f-bce2-aff09c043ecb2
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSY05c006d2-44b9-431f-bce2-aff09c043ecb2
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY05c006d2-44b9-431f-bce2-aff09c043ecb2
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY05c006d2-44b9-431f-bce2-aff09c043ecb2
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY05c006d2-44b9-431f-bce2-aff09c043ecb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-393-0159651039301100 TABLET in 1 BOTTLE (59651-393-01) 100 tablet2020-02-210000-00-00NoNoCurrent
59651-393-0559651039305500 TABLET in 1 BOTTLE (59651-393-05) 500 tablet2020-02-210000-00-00NoNoCurrent
59651-393-105965103931010 BLISTER PACK in 1 CARTON (59651-393-10) / 10 TABLET in 1 BLISTER PACK10 blister pack2020-02-210000-00-00NoNoCurrent
59651-393-305965103933030 TABLET in 1 BOTTLE (59651-393-30) 30 tablet2020-02-210000-00-00NoNoCurrent
59651-393-605965103936060 TABLET in 1 BOTTLE (59651-393-60) 60 tablet2020-02-210000-00-00NoNoCurrent