duloxetine

Product NDC
80175-0583
11-digit product format
801750583
Labeler code
80175
Product ID
80175-0583_bcd11524-8112-5c7f-e053-2995a90a457a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Central Packaging
Application
ANDA204343
Marketing category
ANDA
Marketing start
2016-08-11
Marketing end
0000-00-00
Substance
DULOXETINE HYDROCHLORIDE
Active strength
60 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80175-0583-38017505830330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80175-0583-3) 2016-08-110000-00-00NoNoCurrent