FDA.reportPublic FDA data

Escitalopram

Product NDC
70518-2597
11-digit product format
705182597
Labeler code
70518
Product ID
70518-2597_5256dcb4-9d77-1ecf-e063-6394a90a692f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078032
Marketing category
ANDA
Marketing start
2020-02-25
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Escitalopram
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESCITALOPRAM OXALATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui351249

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615Product name620170718

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2597-02022-01-30C16284748780-1d6a99b39-ca80-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
70518-2597-02022-01-30C16284748780-1d6a99b39-ca80-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
70518-2597-02022-01-28C16284748780-1d6a99b39-ca80-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
70518-2597-02022-01-28C16284748780-1d6a99b39-ca80-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2597-0Escitalopram100 in 1 BOXTABLET, FILM COATED10014
70518-2597-1Escitalopram1 in 1 POUCHTABLET, FILM COATED114
70518-2597-2Escitalopram30 in 1 BLISTER PACKTABLET, FILM COATED3014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2597ESCITALOPRAM TABLET, FILM COATED [REMEDYREPACK INC.]9Current NDC, Legacy NDC, 3 package rows20250124_83a642b9-acee-45d3-95a1-52a491b770fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351249escitalopram oxalate 5 MG Oral TabletPSN83a642b9-acee-45d3-95a1-52a491b770fd14
351249escitalopram 5 MG Oral TabletSCD83a642b9-acee-45d3-95a1-52a491b770fd14
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY83a642b9-acee-45d3-95a1-52a491b770fd14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2597-070518259700100 POUCH in 1 BOX (70518-2597-0) > 1 TABLET, FILM COATED in 1 POUCH (70518-2597-1) 100 pouch2020-02-250000-00-00NoNoCurrent
70518-2597-1705182597011 in 1 POUCHHistorical
70518-2597-27051825970230 TABLET, FILM COATED in 1 BLISTER PACK (70518-2597-2) 2023-09-19NoNoHistorical