Buspirone Hydrochloride

Product NDC
71335-1938
11-digit product format
713351938
Labeler code
71335
Product ID
71335-1938_459d57f6-0b83-43b4-8cdd-921fa72a2818
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075388
Marketing category
ANDA
Marketing start
2020-07-27
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA Listing Details

Product ID
71335-1938_459d57f6-0b83-43b4-8cdd-921fa72a2818
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
Buspirone Hydrochloride
Generic name
buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Marketing start
2020-07-27
Marketing category
ANDA
Application number
ANDA075388
Listing expiration
2026-12-31

Related Records

openFDA Active Ingredients

IngredientStrength
BUSPIRONE HYDROCHLORIDE5 mg/1

openFDA Harmonized Identifiers

FieldValues
Unii207LT9J9OC
Rxcui866094
Spl Set Id2df0b238-14a4-40ca-a235-411f6c9b8338
Manufacturer NameBryant Ranch Prepack

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1938-17133519380190 TABLET in 1 BOTTLE (71335-1938-1) 90 tablet2021-10-270000-00-00NoNoCurrent
71335-1938-27133519380245 TABLET in 1 BOTTLE (71335-1938-2) 45 tablet2024-04-080000-00-00NoNoCurrent
71335-1938-37133519380330 TABLET in 1 BOTTLE (71335-1938-3) 30 tablet2022-06-030000-00-00NoNoCurrent
71335-1938-47133519380460 TABLET in 1 BOTTLE (71335-1938-4) 60 tablet2022-09-260000-00-00NoNoCurrent
71335-1938-571335193805180 TABLET in 1 BOTTLE (71335-1938-5) 180 tablet2024-04-080000-00-00NoNoCurrent
71335-1938-671335193806120 TABLET in 1 BOTTLE (71335-1938-6) 120 tablet2024-04-080000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Buspirone Hydrochloride - Bryant Ranch PrepackBryant Ranch Prepack2025-10-06HUMAN PRESCRIPTION DRUG LABEL104