SERTRALINE HYDROCHLORIDE

Product NDC
68071-4029
11-digit product format
680714029
Labeler code
68071
Product ID
68071-4029_e313b30f-fbb7-577f-e053-2a95a90a0a38
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
100 mg/1
Pharmacologic classes
Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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
68071-4029-26807140290228 TABLET, FILM COATED in 1 BOTTLE (68071-4029-2) 2017-08-020000-00-00NoNoCurrent
68071-4029-36807140290330 TABLET, FILM COATED in 1 BOTTLE (68071-4029-3) 2017-08-020000-00-00NoNoCurrent
68071-4029-66807140290660 TABLET, FILM COATED in 1 BOTTLE (68071-4029-6) 2017-08-020000-00-00NoNoCurrent
68071-4029-96807140290990 TABLET, FILM COATED in 1 BOTTLE (68071-4029-9) 2017-08-020000-00-00NoNoCurrent