Duloxetine

Product NDC
60760-759
11-digit product format
607600759
Labeler code
60760
Product ID
60760-759_39fa5490-f66d-79af-e063-6294a90a22ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA208706
Marketing category
ANDA
Marketing start
2017-03-16
Substance
DULOXETINE HYDROCHLORIDE
Active strength
20 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
O5TNM5N07UDULOXETINE116539-59-4Duloxetine

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60760-759-306076007593030 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-759-30) 2025-07-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
DuloxetineST. MARY'S MEDICAL PARK PHARMACY2025-07-15HUMAN PRESCRIPTION DRUG LABEL1