BUSPIRONE HYDROCHLORIDE

Product NDC
80425-0334
11-digit product format
804250334
Labeler code
80425
Product ID
80425-0334_2a9bad62-b308-697c-e063-6294a90aa395
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUSPIRONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA078246
Marketing category
ANDA
Marketing start
2023-05-19
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
5 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 HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866094

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
80425-0334-1BUSPIRONE HYDROCHLORIDE30 in 1 BOTTLETABLET302
80425-0334-2BUSPIRONE HYDROCHLORIDE60 in 1 BOTTLETABLET602
80425-0334-3BUSPIRONE HYDROCHLORIDE90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0334-1EA - Each80425-033478f64bd8-99ef-4093-9bf6-9299da53d58c12023-06-06
80425-0334-2EA - Each80425-033443b9693a-2b62-4bf2-973d-313641c5508d12023-06-06
80425-0334-3EA - Each80425-03340f571be5-bdf7-48f5-81e7-57411631671912023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0334BUSPIRONE HYDROCHLORIDE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_fc0f93c8-2078-b2ff-e053-6294a90aacdf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866094busPIRone HCl 5 MG Oral TabletPSNfc0f93c8-2078-b2ff-e053-6294a90aacdf2
866094buspirone hydrochloride 5 MG Oral TabletSCDfc0f93c8-2078-b2ff-e053-6294a90aacdf2
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSYfc0f93c8-2078-b2ff-e053-6294a90aacdf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0334-18042503340130 TABLET in 1 BOTTLE (80425-0334-1) 30 tablet2023-05-19NoNoHistorical
80425-0334-28042503340260 TABLET in 1 BOTTLE (80425-0334-2) 60 tablet2023-05-19NoNoHistorical
80425-0334-38042503340390 TABLET in 1 BOTTLE (80425-0334-3) 90 tablet2023-05-19NoNoHistorical