FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
71335-0007
11-digit product format
713350007
Labeler code
71335
Product ID
71335-0007_3c65de96-b9f1-4539-8b57-33f9a728dc1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202557
Marketing category
ANDA
Marketing start
2016-12-15
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Buspirone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUSPIRONE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866083

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
71335-0007-1Buspirone Hydrochloride30 in 1 BOTTLETABLET30104
71335-0007-2Buspirone Hydrochloride60 in 1 BOTTLETABLET60104
71335-0007-3Buspirone Hydrochloride90 in 1 BOTTLETABLET90104
71335-0007-4Buspirone Hydrochloride45 in 1 BOTTLETABLET45104
71335-0007-5Buspirone Hydrochloride180 in 1 BOTTLETABLET180104
71335-0007-6Buspirone Hydrochloride120 in 1 BOTTLETABLET120104
71335-0007-7Buspirone Hydrochloride10 in 1 BOTTLETABLET10104
71335-0007-8Buspirone Hydrochloride100 in 1 BOTTLETABLET100104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0007-1EA - Each71335-00077b8437a0-b7aa-4ece-885c-937f75edfc8612019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0007BUSPIRONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 8 package rows20240724_66df7f74-5dea-46d6-9ef8-9bab37baf407.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN66df7f74-5dea-46d6-9ef8-9bab37baf407104
866083buspirone hydrochloride 10 MG Oral TabletSCD66df7f74-5dea-46d6-9ef8-9bab37baf407104
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY66df7f74-5dea-46d6-9ef8-9bab37baf407104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0007-17133500070130 TABLET in 1 BOTTLE (71335-0007-1) 30 tablet2026-05-140000-00-00NoNoCurrent
71335-0007-27133500070260 TABLET in 1 BOTTLE (71335-0007-2) 60 tablet2026-05-140000-00-00NoNoCurrent
71335-0007-37133500070390 TABLET in 1 BOTTLE (71335-0007-3) 90 tablet2026-05-140000-00-00NoNoCurrent
71335-0007-47133500070445 TABLET in 1 BOTTLE (71335-0007-4) 45 tablet2026-05-140000-00-00NoNoCurrent
71335-0007-571335000705180 TABLET in 1 BOTTLE (71335-0007-5) 180 tablet2026-05-140000-00-00NoNoCurrent
71335-0007-671335000706120 TABLET in 1 BOTTLE (71335-0007-6) 120 tablet2026-05-140000-00-00NoNoCurrent
71335-0007-77133500070710 TABLET in 1 BOTTLE (71335-0007-7) 10 tablet2026-05-14NoNoCurrent
71335-0007-871335000708100 TABLET in 1 BOTTLE (71335-0007-8) 100 tablet2026-05-14NoNoCurrent