Buspirone Hydrochloride

Product NDC
71610-165
11-digit product format
716100165
Labeler code
71610
Product ID
71610-165_a80c0ae3-f047-4f97-bddd-0de411fd19ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA202557
Marketing category
ANDA
Marketing start
2016-12-15
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
71610-165-53Buspirone Hydrochloride60 in 1 BOTTLETABLET601
71610-165-60Buspirone Hydrochloride90 in 1 BOTTLETABLET901
71610-165-80Buspirone Hydrochloride180 in 1 BOTTLETABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-165-53EA - Each71610-165646504a8-3fac-41bf-b047-ea52a9f8cec712018-12-13
71610-165-60EA - Each71610-16527c8bab6-ffcb-43d1-900b-82201eb1d26b12018-12-13
71610-165-80EA - Each71610-1658a357769-e547-4e40-8118-842edb813c8f12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-165BUSPIRONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 3 package rows20181023_8b6e7ae6-5b83-4a5a-ab45-cf4be4287d78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866094busPIRone HCl 5 MG Oral TabletPSN8b6e7ae6-5b83-4a5a-ab45-cf4be4287d781
866094buspirone hydrochloride 5 MG Oral TabletSCD8b6e7ae6-5b83-4a5a-ab45-cf4be4287d781
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY8b6e7ae6-5b83-4a5a-ab45-cf4be4287d781

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-165-537161001655360 TABLET in 1 BOTTLE (71610-165-53) 60 tablet2018-09-280000-00-00NoNoCurrent
71610-165-607161001656090 TABLET in 1 BOTTLE (71610-165-60) 90 tablet2018-09-280000-00-00NoNoCurrent
71610-165-8071610016580180 TABLET in 1 BOTTLE (71610-165-80) 180 tablet2018-09-280000-00-00NoNoCurrent