Duloxetine

Product NDC
68788-7828
11-digit product format
687887828
Labeler code
68788
Product ID
68788-7828_bec0b6d6-e8e1-40c8-ab15-1d3c9606efd9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Duloxetine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA203197
Marketing category
ANDA
Marketing start
2021-01-08
Marketing end
0000-00-00
Substance
DULOXETINE HYDROCHLORIDE
Active strength
30 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
68788-7828-0687887828006 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7828-0) 2021-01-080000-00-00NoNoCurrent
68788-7828-16878878280110 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7828-1) 2021-01-080000-00-00NoNoCurrent
68788-7828-26878878280220 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7828-2) 2021-01-080000-00-00NoNoCurrent
68788-7828-36878878280330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7828-3) 2021-01-080000-00-00NoNoCurrent
68788-7828-66878878280660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7828-6) 2021-01-080000-00-00NoNoCurrent
68788-7828-96878878280990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7828-9) 2021-01-080000-00-00NoNoCurrent