FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
63187-904
11-digit product format
631870904
Labeler code
63187
Product ID
63187-904_09702e4f-a98d-4284-a95d-1d560ee4dce9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA075022
Marketing category
ANDA
Marketing start
2002-02-28
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866083

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
63187-904-30Buspirone Hydrochloride30 in 1 BOTTLETABLET305
63187-904-60Buspirone Hydrochloride60 in 1 BOTTLETABLET605
63187-904-90Buspirone Hydrochloride90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-904-30EA - Each63187-904b20d5cc5-92b2-4bc2-a5d3-633f0e449a5012019-09-05
63187-904-60EA - Each63187-9047e6915c1-8ba3-4c28-a09d-a010765f538912023-03-13
63187-904-90EA - Each63187-904a6b48b42-9c88-4052-a7da-c2d2d1fc424612017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-904BUSPIRONE HYDROCHLORIDE TABLET [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20220426_69eb15e9-c33e-40a3-82d8-497dad13068d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN69eb15e9-c33e-40a3-82d8-497dad13068d5
866083buspirone hydrochloride 10 MG Oral TabletSCD69eb15e9-c33e-40a3-82d8-497dad13068d5
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY69eb15e9-c33e-40a3-82d8-497dad13068d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-904-306318709043030 TABLET in 1 BOTTLE (63187-904-30) 30 tablet2017-09-010000-00-00NoNoCurrent
63187-904-606318709046060 TABLET in 1 BOTTLE (63187-904-60) 60 tablet2017-09-010000-00-00NoNoCurrent
63187-904-906318709049090 TABLET in 1 BOTTLE (63187-904-90) 90 tablet2017-09-010000-00-00NoNoCurrent