Duloxetine

Product NDC
50268-271
11-digit product format
502680271
Labeler code
50268
Product ID
50268-271_dfd69774-f807-f9ba-e053-2a95a90a7cab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
AvPAK
Application
ANDA204343
Marketing category
ANDA
Marketing start
2022-05-18
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-271-11EA - Each50268-27107817e46-5626-4875-a9b6-7963281571ad12022-06-06
50268-271-13EA - Each50268-271efc6e939-198a-4993-8314-47978d3e7ee912022-06-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-271-135026802711330 BLISTER PACK in 1 BOX (50268-271-13) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (50268-271-11) 30 blister pack2022-05-180000-00-00NoNoCurrent