Duloxetine

Product NDC
50268-286
11-digit product format
502680286
Labeler code
50268
Product ID
50268-286_d5cef9cd-9b5d-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
2020-07-27
Marketing end
0000-00-00
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
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
50268-286-11EA - Each50268-2861d8f89c4-4bde-4457-b06c-4846e2cd104112020-09-14
50268-286-15EA - Each50268-2869553b1e1-308a-412d-90bd-f30d7f7d212612020-09-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-286-155026802861550 BLISTER PACK in 1 BOX (50268-286-15) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (50268-286-11) 50 blister pack2020-07-270000-00-00NoNoCurrent