Buspirone Hydrochloride

Product NDC
72789-332
11-digit product format
727890332
Labeler code
72789
Product ID
72789-332_401ffb0a-e4c9-09e1-e063-6294a90ade8b
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
15 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 HYDROCHLORIDE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866018

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
72789-332-60Buspirone Hydrochloride60 in 1 BOTTLE, PLASTICTABLET608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-332-60EA - Each72789-332270f719d-2970-4205-9448-881271ee826d12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-332BUSPIRONE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6Current NDC, 1 package rows20240802_270398a0-21b8-407b-af76-4aeef90f72be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866018busPIRone HCl 15 MG Oral TabletPSN270398a0-21b8-407b-af76-4aeef90f72be8
866018buspirone hydrochloride 15 MG Oral TabletSCD270398a0-21b8-407b-af76-4aeef90f72be8
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY270398a0-21b8-407b-af76-4aeef90f72be8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-332-607278903326060 TABLET in 1 BOTTLE, PLASTIC (72789-332-60) 60 tablet2023-07-28NoNoHistorical