DULOXETINE

Product NDC
70518-1128
11-digit product format
705181128
Labeler code
70518
Product ID
70518-1128_e3107384-eac9-3bc2-e053-2a95a90a9228
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA206653
Marketing category
ANDA
Marketing start
2018-04-19
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1128-07051811280030 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-1128-0) 2018-04-190000-00-00NoNoCurrent