Buspirone Hydrochloride

Product NDC
0615-8434
11-digit product format
006158434
Labeler code
0615
Product ID
0615-8434_53468e3e-9a6e-4f97-b3f4-8e73e633a97e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA202330
Marketing category
ANDA
Marketing start
2017-02-17
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0615-8434-39Buspirone Hydrochloride30 in 1 BLISTER PACKTABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8434BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]5Current NDC, Legacy NDC, 1 package rows20240814_da6f4a74-a71e-4ccc-af2c-8de29e909c3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866111busPIRone HCl 7.5 MG Oral TabletPSNda6f4a74-a71e-4ccc-af2c-8de29e909c3b5
866111buspirone hydrochloride 7.5 MG Oral TabletSCDda6f4a74-a71e-4ccc-af2c-8de29e909c3b5
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSYda6f4a74-a71e-4ccc-af2c-8de29e909c3b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8434-390061584343930 TABLET in 1 BLISTER PACK (0615-8434-39) 30 tablet2022-07-140000-00-00NoNoCurrent