Buspirone Hydrochloride

Product NDC
0615-8527
11-digit product format
006158527
Labeler code
0615
Product ID
0615-8527_1999411b-cc4c-4dac-a2de-c3a4dacfa1d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA075022
Marketing category
ANDA
Marketing start
2004-03-26
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
30 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
207LT9J9OCBUSPIRONE HYDROCHLORIDE33386-08-2BUSPIRONE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0615-8527-390061585273930 TABLET in 1 BLISTER PACK (0615-8527-39) 30 tablet2024-09-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
BusPIRone Hydrochloride Tablets, USP Rx onlyNCS HealthCare of KY, LLC dba Vangard Labs2024-09-27HUMAN PRESCRIPTION DRUG LABEL2