Buspirone Hydrochloride

Product NDC
68071-2995
11-digit product format
680712995
Labeler code
68071
Product ID
68071-2995_2d53e84a-506a-e4c8-e063-6294a90a3f8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA210907
Marketing category
ANDA
Marketing start
2019-11-14
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
5 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
68071-2995-36807129950330 TABLET in 1 BOTTLE, PLASTIC (68071-2995-3) 30 tablet2023-05-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Buspirone Hydrochloride Tablets, USP Rx OnlyNuCare Pharmaceuticals,Inc.2025-02-04HUMAN PRESCRIPTION DRUG LABEL2