Buspirone Hydrochloride

Product NDC
72789-181
11-digit product format
727890181
Labeler code
72789
Product ID
72789-181_4019e519-dc9e-1fc4-e063-6294a90a8865
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
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
72789-181-90Buspirone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET9011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-181BUSPIRONE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]10Current NDC, Legacy NDC, 1 package rows20240412_b217f341-7d51-475d-887f-f16786164c7b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSNb217f341-7d51-475d-887f-f16786164c7b11
866083buspirone hydrochloride 10 MG Oral TabletSCDb217f341-7d51-475d-887f-f16786164c7b11
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYb217f341-7d51-475d-887f-f16786164c7b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-181-907278901819090 TABLET in 1 BOTTLE, PLASTIC (72789-181-90) 90 tablet2021-04-130000-00-00NoNoCurrent