SERTRALINE HYDROCHLORIDE

Product NDC
59762-6443
11-digit product format
597626443
Labeler code
59762
Product ID
59762-6443_e73de26b-297b-4a29-b4d2-8d59e6c70320
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sertraline hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Greenstone LLC
Application
NDA019839
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-08-12
Marketing end
0000-00-00
Substance
SERTRALINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-6443-1EA - Each59762-6443940678b2-7d24-4520-bfe9-52d5e484ad3412019-09-05
59762-6443-2EA - Each59762-6443bdbef115-8732-4951-8507-c750c5b9d7b312019-09-05
59762-6443-3EA - Each59762-6443c437c87b-1468-4390-ac8d-a89b3a8b4df412019-09-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59762-6443-15976264430130 TABLET, FILM COATED in 1 BOTTLE (59762-6443-1) 2019-08-120000-00-00NoNoCurrent
59762-6443-259762644302100 TABLET, FILM COATED in 1 BOTTLE (59762-6443-2) 2019-08-120000-00-00NoNoCurrent
59762-6443-359762644303500 TABLET, FILM COATED in 1 BOTTLE (59762-6443-3) 2019-08-120000-00-00NoNoCurrent