Duloxetine

Product NDC
71610-739
11-digit product format
716100739
Labeler code
71610
Product ID
71610-739_14c0b109-4960-6df5-e063-6394a90a4c51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DULOXETINE HYDROCHLORIDE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
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
71610-739-16716100739166000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-739-16) 2024-01-08NoNoHistorical
71610-739-3371610073933840 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-739-33) 2024-03-22NoNoHistorical
71610-739-7471610073974500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-739-74) 2023-09-27NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Duloxetine Delayed-Release - Aphena Pharma Solutions - Tennessee, LLCAphena Pharma Solutions - Tennessee, LLC2024-03-28HUMAN PRESCRIPTION DRUG LABEL3