Duloxetine

Product NDC
50268-288
11-digit product format
502680288
Labeler code
50268
Product ID
50268-288_d5cef9cd-9b5e-8bbc-e053-2995a90a2c7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
AvPAK
Application
ANDA204343
Marketing category
ANDA
Marketing start
2020-09-21
Marketing end
0000-00-00
Substance
DULOXETINE HYDROCHLORIDE
Active strength
60 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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-288-135026802881330 BLISTER PACK in 1 BOX (50268-288-13) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (50268-288-11) 30 blister pack2020-09-210000-00-00NoNoCurrent