Buspirone Hydrochloride

Product NDC
71610-404
11-digit product format
716100404
Labeler code
71610
Product ID
71610-404_a93360e6-43f6-4652-a7ef-07087a718258
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA208972
Marketing category
ANDA
Marketing start
2019-04-17
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
7.5 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 HYDROCHLORIDE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866111

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
71610-404-60Buspirone Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-404-60EA - Each71610-404d69c2077-f4ee-4825-a9d3-8319b157489212020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-404BUSPIRONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 1 package rows20200414_27db85e9-68ef-4d43-a319-4e2ec8dbae05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866111busPIRone HCl 7.5 MG Oral TabletPSN27db85e9-68ef-4d43-a319-4e2ec8dbae051
866111buspirone hydrochloride 7.5 MG Oral TabletSCD27db85e9-68ef-4d43-a319-4e2ec8dbae051
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSY27db85e9-68ef-4d43-a319-4e2ec8dbae051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-404-607161004046090 TABLET in 1 BOTTLE (71610-404-60) 90 tablet2020-03-090000-00-00NoNoCurrent