FDA.reportPublic FDA data

Buspirone HCL

Product NDC
72189-448
11-digit product format
721890448
Labeler code
72189
Product ID
72189-448_2f365a80-62cf-95d6-e063-6394a90af5c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone HCL
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA210907
Marketing category
ANDA
Marketing start
2023-03-17
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 HCL
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
72189-448-30Buspirone HCL30 in 1 BOTTLETABLET305
72189-448-60Buspirone HCL60 in 1 BOTTLETABLET605
72189-448-82Buspirone HCL180 in 1 BOTTLETABLET1805
72189-448-90Buspirone HCL90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-448-30EA - Each72189-448a6c1db5c-52f6-46ac-8d25-61182b0319f212025-05-14
72189-448-60EA - Each72189-44801e32761-6457-4b48-9fe0-6b3a1dcdd26812023-05-05
72189-448-82EA - Each72189-448ca63de1b-dc68-4429-b7e1-e7d093133e4b12024-06-10
72189-448-90EA - Each72189-448ff21eebe-b4e8-4f35-80f1-e68ba1fe74d712023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-448BUSPIRONE HCL TABLET [DIRECT_RX]5Current NDC, 4 package rows20250302_f71e019b-3928-f8eb-e053-6394a90a871e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSNf71e019b-3928-f8eb-e053-6394a90a871e5
866083buspirone hydrochloride 10 MG Oral TabletSCDf71e019b-3928-f8eb-e053-6394a90a871e5
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYf71e019b-3928-f8eb-e053-6394a90a871e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-448-307218904483030 TABLET in 1 BOTTLE (72189-448-30) 30 tablet2023-03-17NoNoHistorical
72189-448-607218904486060 TABLET in 1 BOTTLE (72189-448-60) 60 tablet2023-03-17NoNoHistorical
72189-448-8272189044882180 TABLET in 1 BOTTLE (72189-448-82) 180 tablet2023-03-17NoNoHistorical
72189-448-907218904489090 TABLET in 1 BOTTLE (72189-448-90) 90 tablet2023-03-17NoNoHistorical