FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
42806-084
11-digit product format
428060084
Labeler code
42806
Product ID
42806-084_02628a0c-bfdb-4a58-8e48-bcd8ca12d53b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA208972
Marketing category
ANDA
Marketing start
2019-04-17
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866018, 866083, 866090, 866094, 866111

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
42806-084-01Buspirone Hydrochloride100 in 1 BOTTLETABLET1001
42806-084-05Buspirone Hydrochloride500 in 1 BOTTLETABLET5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-084BUSPIRONE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]1Current NDC, Legacy NDC, 2 package rows20190426_02628a0c-bfdb-4a58-8e48-bcd8ca12d53b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN02628a0c-bfdb-4a58-8e48-bcd8ca12d53b1
866018busPIRone HCl 15 MG Oral TabletPSN02628a0c-bfdb-4a58-8e48-bcd8ca12d53b1
866090busPIRone HCl 30 MG Oral TabletPSN02628a0c-bfdb-4a58-8e48-bcd8ca12d53b1
866094busPIRone HCl 5 MG Oral TabletPSN02628a0c-bfdb-4a58-8e48-bcd8ca12d53b1
866111busPIRone HCl 7.5 MG Oral TabletPSN02628a0c-bfdb-4a58-8e48-bcd8ca12d53b1
866083buspirone hydrochloride 10 MG Oral TabletSCD02628a0c-bfdb-4a58-8e48-bcd8ca12d53b1
866018buspirone hydrochloride 15 MG Oral TabletSCD02628a0c-bfdb-4a58-8e48-bcd8ca12d53b1
866090buspirone hydrochloride 30 MG Oral TabletSCD02628a0c-bfdb-4a58-8e48-bcd8ca12d53b1
866094buspirone hydrochloride 5 MG Oral TabletSCD02628a0c-bfdb-4a58-8e48-bcd8ca12d53b1
866111buspirone hydrochloride 7.5 MG Oral TabletSCD02628a0c-bfdb-4a58-8e48-bcd8ca12d53b1
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY02628a0c-bfdb-4a58-8e48-bcd8ca12d53b1
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSY02628a0c-bfdb-4a58-8e48-bcd8ca12d53b1
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY02628a0c-bfdb-4a58-8e48-bcd8ca12d53b1
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY02628a0c-bfdb-4a58-8e48-bcd8ca12d53b1
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY02628a0c-bfdb-4a58-8e48-bcd8ca12d53b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-084-0142806008401100 TABLET in 1 BOTTLE (42806-084-01) 100 tablet2019-04-170000-00-00NoNoCurrent
42806-084-0542806008405500 TABLET in 1 BOTTLE (42806-084-05) 500 tablet2019-04-170000-00-00NoNoCurrent