FDA.reportPublic FDA data

Escitalopram

Product NDC
70518-2472
11-digit product format
705182472
Labeler code
70518
Product ID
70518-2472_5256866f-0845-bba5-e063-6394a90ad95e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078032
Marketing category
ANDA
Marketing start
2019-12-06
Substance
ESCITALOPRAM OXALATE
Active strength
10 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 OXALATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui349332

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
70518-2472-02023-02-23C16284748780-1f386c649-c6bf-0266-e053-dadaa90a7c1aThese 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
70518-2472-02023-02-23C16284748780-1f386c649-c6bf-0266-e053-dadaa90a7c1aThese 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
70518-2472-12023-02-23C16284748780-1f386c649-c6bf-0266-e053-dadaa90a7c1aThese 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
70518-2472-12023-02-23C16284748780-1f386c649-c6bf-0266-e053-dadaa90a7c1aThese 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
70518-2472-22023-02-23C16284748780-1f386c649-c6bf-0266-e053-dadaa90a7c1aThese 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
70518-2472-22023-02-23C16284748780-1f386c649-c6bf-0266-e053-dadaa90a7c1aThese 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
70518-2472-32023-02-23C16284748780-1f386c649-c6bf-0266-e053-dadaa90a7c1aThese 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
70518-2472-32023-02-23C16284748780-1f386c649-c6bf-0266-e053-dadaa90a7c1aThese 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
70518-2472-02023-01-30C16284748780-1f386c649-c6bf-0266-e053-dadaa90a7c1aThese 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
70518-2472-02023-01-30C16284748780-1f386c649-c6bf-0266-e053-dadaa90a7c1aThese 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
70518-2472-12023-01-30C16284748780-1f386c649-c6bf-0266-e053-dadaa90a7c1aThese 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
70518-2472-12023-01-30C16284748780-1f386c649-c6bf-0266-e053-dadaa90a7c1aThese 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
70518-2472-22023-01-30C16284748780-1f386c649-c6bf-0266-e053-dadaa90a7c1aThese 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
70518-2472-22023-01-30C16284748780-1f386c649-c6bf-0266-e053-dadaa90a7c1aThese 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
70518-2472-32023-01-30C16284748780-1f386c649-c6bf-0266-e053-dadaa90a7c1aThese 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
70518-2472-32023-01-30C16284748780-1f386c649-c6bf-0266-e053-dadaa90a7c1aThese 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
70518-2472-0Escitalopram30 in 1 BLISTER PACKTABLET, FILM COATED3013
70518-2472-1Escitalopram90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9013
70518-2472-2Escitalopram30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3013
70518-2472-3Escitalopram60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6013
70518-2472-4Escitalopram30 in 1 BLISTER PACKTABLET, FILM COATED3013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2472ESCITALOPRAM TABLET, FILM COATED [REMEDYREPACK INC.]9Current NDC, Legacy NDC, 5 package rows20250123_b6fbd554-9da7-40fd-87a5-2c4af2aa3e6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSNb6fbd554-9da7-40fd-87a5-2c4af2aa3e6c13
349332escitalopram 10 MG Oral TabletSCDb6fbd554-9da7-40fd-87a5-2c4af2aa3e6c13
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYb6fbd554-9da7-40fd-87a5-2c4af2aa3e6c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2472-07051824720030 TABLET, FILM COATED in 1 BLISTER PACK (70518-2472-0) 2019-12-060000-00-00NoNoCurrent
70518-2472-17051824720190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2472-1) 2020-04-220000-00-00NoNoCurrent
70518-2472-27051824720230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2472-2) 2020-09-220000-00-00NoNoCurrent
70518-2472-37051824720360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2472-3) 2020-10-150000-00-00NoNoCurrent
70518-2472-47051824720430 in 1 BLISTER PACKHistorical