FDA.reportPublic FDA data

BUSPIRONE HYDROCHLORIDE

Product NDC
59651-390
11-digit product format
596510390
Labeler code
59651
Product ID
59651-390_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
7.5 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 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
59651-390-01BUSPIRONE HYDROCHLORIDE100 in 1 BOTTLETABLET1002
59651-390-05BUSPIRONE HYDROCHLORIDE500 in 1 BOTTLETABLET5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-390-01EA - Each59651-390a2861384-ff71-4b24-8341-490903cf96d612021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-390BUSPIRONE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]2Current NDC, Legacy NDC, 2 package rows20210706_05c006d2-44b9-431f-bce2-aff09c043ecb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866111busPIRone HCl 7.5 MG Oral TabletPSN55e32128-711d-4e95-b58b-e86e0afa4983102
866111buspirone hydrochloride 7.5 MG Oral TabletSCD55e32128-711d-4e95-b58b-e86e0afa4983102
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSY55e32128-711d-4e95-b58b-e86e0afa4983102
866111busPIRone HCl 7.5 MG Oral TabletPSN529ab1f9-534c-4a45-aa70-76e605247af17
866111buspirone hydrochloride 7.5 MG Oral TabletSCD529ab1f9-534c-4a45-aa70-76e605247af17
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSY529ab1f9-534c-4a45-aa70-76e605247af17
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 TabletPSNfa4d5cac-f687-4440-99d2-8bb27cf2f4ed2
866111busPIRone HCl 7.5 MG Oral TabletPSN75b1ae3f-e926-4555-a0e9-50323fc66cb22
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 TabletSCD75b1ae3f-e926-4555-a0e9-50323fc66cb22
866111buspirone hydrochloride 7.5 MG Oral TabletSCD05c006d2-44b9-431f-bce2-aff09c043ecb2
866111buspirone hydrochloride 7.5 MG Oral TabletSCDfa4d5cac-f687-4440-99d2-8bb27cf2f4ed2
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
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSY75b1ae3f-e926-4555-a0e9-50323fc66cb22
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSYfa4d5cac-f687-4440-99d2-8bb27cf2f4ed2
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
59651-390-0159651039001100 TABLET in 1 BOTTLE (59651-390-01) 100 tablet2020-02-210000-00-00NoNoCurrent
59651-390-0559651039005500 TABLET in 1 BOTTLE (59651-390-05) 500 tablet2020-02-210000-00-00NoNoCurrent