Fluoxetine

Product NDC
72162-1506
11-digit product format
721621506
Labeler code
72162
Product ID
72162-1506_cf0b39d7-583f-43cc-9737-e28c00ff392c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209419
Marketing category
ANDA
Marketing start
2017-11-16
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
60 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
I9W7N6B1KJFLUOXETINE HYDROCHLORIDE56296-78-7FLUOXETINE HYDROCHLORIDE
01K63SUP8DFLUOXETINE54910-89-3Fluoxetine

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1506-37216215060330 TABLET, FILM COATED in 1 BOTTLE (72162-1506-3) 2024-04-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
FluoxetineBryant Ranch Prepack2024-04-11HUMAN PRESCRIPTION DRUG LABEL103