BusPIRone Hydrochloride

Product NDC
71205-280
11-digit product format
712050280
Labeler code
71205
Product ID
71205-280_b02f563b-a2cb-42f8-932c-8e307467a300
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BusPIRone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA209696
Marketing category
ANDA
Marketing start
2018-07-03
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
71205-280-30BusPIRone Hydrochloride30 in 1 BOTTLETABLET302
71205-280-60BusPIRone Hydrochloride60 in 1 BOTTLETABLET602
71205-280-90BusPIRone Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-280BUSPIRONE HYDROCHLORIDE TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20200411_03efd618-8ca3-43d0-bbeb-55e53b5308e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866018busPIRone HCl 15 MG Oral TabletPSN03efd618-8ca3-43d0-bbeb-55e53b5308e82
866018buspirone hydrochloride 15 MG Oral TabletSCD03efd618-8ca3-43d0-bbeb-55e53b5308e82
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY03efd618-8ca3-43d0-bbeb-55e53b5308e82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-280-307120502803030 TABLET in 1 BOTTLE (71205-280-30) 30 tablet2019-06-010000-00-00NoNoCurrent
71205-280-607120502806060 TABLET in 1 BOTTLE (71205-280-60) 60 tablet2019-06-010000-00-00NoNoCurrent
71205-280-907120502809090 TABLET in 1 BOTTLE (71205-280-90) 90 tablet2019-06-010000-00-00NoNoCurrent