Duloxetine

Product NDC
68382-386
11-digit product format
683820386
Labeler code
68382
Product ID
68382-386_f95fe0a8-5492-4210-87a3-1881b4e98372
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA090739
Marketing category
ANDA
Marketing start
2014-05-27
Marketing end
0000-00-00
Substance
DULOXETINE HYDROCHLORIDE
Active strength
30 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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-386-06EA - Each68382-386299dccbb-3c55-445a-91b0-49dea880490e12014-12-01
68382-386-16EA - Each68382-386d508ef70-67ec-4e11-a503-1eed57e6c6d212014-12-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-386-066838203860630 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-386-06) 2014-05-270000-00-00NoNoCurrent
68382-386-10683820386101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-386-10) 2017-04-060000-00-00NoNoCurrent
68382-386-166838203861690 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-386-16) 2014-05-270000-00-00NoNoCurrent