Buspirone Hydrochloride

Product NDC
71335-1673
11-digit product format
713351673
Labeler code
71335
Product ID
71335-1673_61818fbc-a7ad-401e-ae2b-2a0567c83b5c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210907
Marketing category
ANDA
Marketing start
2019-11-14
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA Listing Details

Product ID
71335-1673_61818fbc-a7ad-401e-ae2b-2a0567c83b5c
SPL ID
61818fbc-a7ad-401e-ae2b-2a0567c83b5c
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
Buspirone Hydrochloride
Generic name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Marketing start
2019-11-14
Marketing category
ANDA
Application number
ANDA210907
Listing expiration
2026-12-31

openFDA Active Ingredients

IngredientStrength
BUSPIRONE HYDROCHLORIDE10 mg/1

openFDA Harmonized Identifiers

FieldValues
Unii207LT9J9OC
Rxcui866083
Spl Set Idb6352207-e708-44a7-8a63-93b96613e1e7
Manufacturer NameBryant Ranch Prepack

openFDA Package Details

Package NDCDescriptionMarketing startSample
71335-1673-130 TABLET in 1 BOTTLE (71335-1673-1)2020-07-28No
71335-1673-260 TABLET in 1 BOTTLE (71335-1673-2)2020-10-13No
71335-1673-390 TABLET in 1 BOTTLE (71335-1673-3)2021-10-26No
71335-1673-445 TABLET in 1 BOTTLE (71335-1673-4)2024-04-04No
71335-1673-5180 TABLET in 1 BOTTLE (71335-1673-5)2020-07-24No
71335-1673-6120 TABLET in 1 BOTTLE (71335-1673-6)2020-12-22No
71335-1673-710 TABLET in 1 BOTTLE (71335-1673-7)2020-12-22No

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-1673-17133516730130 TABLET in 1 BOTTLE (71335-1673-1) 30 tablet2020-07-28NoNoHistorical
71335-1673-27133516730260 TABLET in 1 BOTTLE (71335-1673-2) 60 tablet2020-10-13NoNoHistorical
71335-1673-37133516730390 TABLET in 1 BOTTLE (71335-1673-3) 90 tablet2021-10-26NoNoHistorical
71335-1673-47133516730445 TABLET in 1 BOTTLE (71335-1673-4) 45 tablet2024-04-04NoNoHistorical
71335-1673-571335167305180 TABLET in 1 BOTTLE (71335-1673-5) 180 tablet2020-07-24NoNoHistorical
71335-1673-671335167306120 TABLET in 1 BOTTLE (71335-1673-6) 120 tablet2020-12-22NoNoHistorical
71335-1673-77133516730710 TABLET in 1 BOTTLE (71335-1673-7) 10 tablet2020-12-22NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Buspirone Hydrochloride Tablets, USP Rx OnlyBryant Ranch Prepack2025-03-27HUMAN PRESCRIPTION DRUG LABEL5