Duloxetine

Product NDC
72162-1600
11-digit product format
721621600
Labeler code
72162
Product ID
72162-1600_075f61b7-af66-42ee-8275-c9d9f01fc074
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DULOXETINE HYDROCHLORIDE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203088
Marketing category
ANDA
Marketing start
2018-05-21
Substance
DULOXETINE HYDROCHLORIDE
Active strength
40 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
9044SC542WDULOXETINE HYDROCHLORIDE136434-34-9DULOXETINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1600-37216216000330 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (72162-1600-3) 2018-05-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Duloxetine Delayed-ReleaseBryant Ranch Prepack2025-04-01HUMAN PRESCRIPTION DRUG LABEL102