Duloxetine

Product NDC
63629-8051
11-digit product format
636298051
Labeler code
63629
Product ID
63629-8051_24930759-b738-41b2-b7af-1094b6ce40f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208706
Marketing category
ANDA
Marketing start
2017-03-16
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-8051-12024-05-13C16284748780-11030e365-5dfd-111a-e063-dadaa90a10e224930759-b738-41b2-b7af-1094b6ce40f8
63629-8051-12024-01-30C16284748780-11030e365-5dfd-111a-e063-dadaa90a10e224930759-b738-41b2-b7af-1094b6ce40f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8051-16362980510130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-8051-1) 2019-08-280000-00-00NoNoCurrent