FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
72789-139
11-digit product format
727890139
Labeler code
72789
Product ID
72789-139_4d512f5f-e5d0-66a9-e063-6294a90a15b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA075388
Marketing category
ANDA
Marketing start
2020-07-27
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
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 Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUSPIRONE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

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

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
72789-139-01Buspirone Hydrochloride100 in 1 BOTTLE, PLASTICTABLET10018
72789-139-60Buspirone Hydrochloride60 in 1 BOTTLE, PLASTICTABLET6018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-139-60EA - Each72789-139eb346813-a07d-4007-84c5-d0f06092f83612026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-139BUSPIRONE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]15Current NDC, Legacy NDC, 2 package rows20250119_476f4f55-c6c1-4f39-950e-59236f499577.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN476f4f55-c6c1-4f39-950e-59236f49957718
866018busPIRone HCl 15 MG Oral TabletPSN476f4f55-c6c1-4f39-950e-59236f49957718
866090busPIRone HCl 30 MG Oral TabletPSN476f4f55-c6c1-4f39-950e-59236f49957718
866094busPIRone HCl 5 MG Oral TabletPSN476f4f55-c6c1-4f39-950e-59236f49957718
866083buspirone hydrochloride 10 MG Oral TabletSCD476f4f55-c6c1-4f39-950e-59236f49957718
866018buspirone hydrochloride 15 MG Oral TabletSCD476f4f55-c6c1-4f39-950e-59236f49957718
866090buspirone hydrochloride 30 MG Oral TabletSCD476f4f55-c6c1-4f39-950e-59236f49957718
866094buspirone hydrochloride 5 MG Oral TabletSCD476f4f55-c6c1-4f39-950e-59236f49957718
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY476f4f55-c6c1-4f39-950e-59236f49957718
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY476f4f55-c6c1-4f39-950e-59236f49957718
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY476f4f55-c6c1-4f39-950e-59236f49957718
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY476f4f55-c6c1-4f39-950e-59236f49957718

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-139-0172789013901100 TABLET in 1 BOTTLE, PLASTIC (72789-139-01) 100 tablet2020-11-060000-00-00NoNoCurrent
72789-139-607278901396060 TABLET in 1 BOTTLE, PLASTIC (72789-139-60) 60 tablet2026-02-24NoNoHistorical