Sertraline Hydrochloride

Product NDC
63629-8127
11-digit product format
636298127
Labeler code
63629
Product ID
63629-8127_2b2ea3ca-628f-40c1-b6b0-d578f5c5fa0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077206
Marketing category
ANDA
Marketing start
2007-02-06
Marketing end
0000-00-00
Substance
SERTRALINE HYDROCHLORIDE
Active strength
25 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
63629-8127-16362981270130 TABLET, FILM COATED in 1 BOTTLE (63629-8127-1) 2019-07-290000-00-00NoNoCurrent
63629-8127-26362981270290 TABLET, FILM COATED in 1 BOTTLE (63629-8127-2) 2019-07-290000-00-00NoNoCurrent