Zoloft

Product NDC
55289-409
11-digit product format
552890409
Labeler code
55289
Product ID
55289-409_d9f5ec03-ceb6-7ea7-e053-2995a90a2dfa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sertraline hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
NDA019839
Marketing category
NDA
Marketing start
1992-02-11
Marketing end
0000-00-00
Substance
SERTRALINE HYDROCHLORIDE
Active strength
50 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-409-30EA - Each55289-4097147bcdc-f340-4aaf-961d-56ad24f85fa112012-07-24
55289-409-60EA - Each55289-409576b9738-5bba-400a-9d6d-bf99b49d46ac12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55289-409-305528904093030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-409-30) 2011-09-080000-00-00NoNoCurrent
55289-409-605528904096060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-409-60) 2011-09-080000-00-00NoNoCurrent