SERTRALINE HYDROCHLORIDE

Product NDC
68071-4750
11-digit product format
680714750
Labeler code
68071
Product ID
68071-4750_bb8d7eda-6cb9-7eda-e053-2995a90aa74f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SERTRALINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA202825
Marketing category
ANDA
Marketing start
2017-02-09
Marketing end
0000-00-00
Substance
SERTRALINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4750-36807147500330 TABLET, FILM COATED in 1 BOTTLE (68071-4750-3) 2019-02-040000-00-00NoNoCurrent