Duloxetine

Product NDC
68071-2711
11-digit product format
680712711
Labeler code
68071
Product ID
68071-2711_2a3465ea-2ceb-400f-e063-6394a90a6b35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DULOXETINE HYDROCHLORIDE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA203088
Marketing category
ANDA
Marketing start
2014-06-11
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

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-2711-96807127110990 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68071-2711-9) 2022-05-19NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Duloxetine Delayed-Release - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2024-12-26HUMAN PRESCRIPTION DRUG LABEL2