Buspirone Hydrochloride

Product NDC
53002-1424
11-digit product format
530021424
Labeler code
53002
Product ID
53002-1424_e6d336e8-f391-4ad3-a42d-8c095035b819
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA075022
Marketing category
ANDA
Marketing start
2002-03-01
Marketing end
0000-00-00
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
15 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-1424-35300214240330 TABLET in 1 BOTTLE (53002-1424-3) 30 tablet2021-01-010000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
BusPIRone Hydrochloride Tablets USP Rx onlyRPK Pharmaceuticals, Inc.2022-03-30HUMAN PRESCRIPTION DRUG LABEL4