escitalopram

Product NDC
70518-4300
11-digit product format
705184300
Labeler code
70518
Product ID
70518-4300_38f2532b-84e2-7b40-e063-6394a90a4aa0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078777
Marketing category
ANDA
Marketing start
2025-03-03
Substance
ESCITALOPRAM OXALATE
Active strength
5 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
5U85DBW7LOESCITALOPRAM OXALATE219861-08-2ESCITALOPRAM OXALATE
4O4S742ANYESCITALOPRAM128196-01-0escitalopram

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4300-07051843000030 TABLET, FILM COATED in 1 BLISTER PACK (70518-4300-0) 2025-03-03NoNoHistorical
70518-4300-17051843000190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4300-1) 2025-07-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
escitalopramREMEDYREPACK INC.2025-07-02HUMAN PRESCRIPTION DRUG LABEL2