SERTRALINE HYDROCHLORIDE

Product NDC
68788-7035
11-digit product format
687887035
Labeler code
68788
Product ID
68788-7035_42ee5084-8347-4790-ab1d-9d50386cee0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SERTRALINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA202825
Marketing category
ANDA
Marketing start
2017-10-16
Marketing end
0000-00-00
Substance
SERTRALINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7035-168788703501100 TABLET, FILM COATED in 1 BOTTLE (68788-7035-1) 2017-10-160000-00-00NoNoCurrent
68788-7035-36878870350330 TABLET, FILM COATED in 1 BOTTLE (68788-7035-3) 2017-10-160000-00-00NoNoCurrent
68788-7035-66878870350660 TABLET, FILM COATED in 1 BOTTLE (68788-7035-6) 2017-10-160000-00-00NoNoCurrent
68788-7035-868788703508120 TABLET, FILM COATED in 1 BOTTLE (68788-7035-8) 2017-10-160000-00-00NoNoCurrent
68788-7035-96878870350990 TABLET, FILM COATED in 1 BOTTLE (68788-7035-9) 2017-10-160000-00-00NoNoCurrent