FDA.reportPublic FDA data

Escitalopram

Product NDC
59746-281
11-digit product format
597460281
Labeler code
59746
Product ID
59746-281_1ba045ea-2f59-4bf4-94b3-d03449c0bf77
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram Oxalate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Jubilant Cadista Pharmacuticals Inc.
Application
ANDA202280
Marketing category
ANDA
Marketing start
2024-01-01
Substance
ESCITALOPRAM OXALATE
Active strength
20 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

Additional Listing Data#

Finished product
Yes
Brand name base
Escitalopram
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESCITALOPRAM OXALATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui349332, 351249, 351250

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
59746-281-012023-11-28C16284748780-1f386c649-9ce5-0266-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
59746-281-012023-11-28C16284748780-1f386c649-9ce5-0266-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
59746-281-052023-11-28C16284748780-1f386c649-9ce5-0266-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
59746-281-052023-11-28C16284748780-1f386c649-9ce5-0266-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
59746-281-102023-11-28C16284748780-1f386c649-9ce5-0266-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
59746-281-102023-11-28C16284748780-1f386c649-9ce5-0266-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
59746-281-302023-11-28C16284748780-1f386c649-9ce5-0266-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
59746-281-302023-11-28C16284748780-1f386c649-9ce5-0266-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
59746-281-902023-11-28C16284748780-1f386c649-9ce5-0266-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
59746-281-902023-11-28C16284748780-1f386c649-9ce5-0266-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
59746-281-012023-01-30C16284748780-1f386c649-9ce5-0266-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
59746-281-012023-01-30C16284748780-1f386c649-9ce5-0266-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
59746-281-052023-01-30C16284748780-1f386c649-9ce5-0266-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
59746-281-052023-01-30C16284748780-1f386c649-9ce5-0266-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
59746-281-102023-01-30C16284748780-1f386c649-9ce5-0266-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
59746-281-102023-01-30C16284748780-1f386c649-9ce5-0266-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
59746-281-302023-01-30C16284748780-1f386c649-9ce5-0266-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
59746-281-302023-01-30C16284748780-1f386c649-9ce5-0266-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
59746-281-902023-01-30C16284748780-1f386c649-9ce5-0266-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
59746-281-902023-01-30C16284748780-1f386c649-9ce5-0266-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
59746-281-01Escitalopram100 in 1 BOTTLETABLET, FILM COATED10014
59746-281-05Escitalopram500 in 1 BOTTLETABLET, FILM COATED50014
59746-281-10Escitalopram1000 in 1 BOTTLETABLET, FILM COATED100014
59746-281-30Escitalopram30 in 1 BOTTLETABLET, FILM COATED3014
59746-281-90Escitalopram90 in 1 BOTTLETABLET, FILM COATED9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-281-01EA - Each59746-28120084055-b15c-46d9-82da-6a812d6ba16912013-10-17
59746-281-10EA - Each59746-281c716317c-260c-4c6d-9a63-f186c9c2e48212024-03-12
59746-281-90EA - Each59746-2818a14c9db-e6d0-4ee6-99e1-a3f0fa9267f312025-07-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Escitalopram oxalateACTIVE INGREDIENT5U85DBW7LOESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]8
EscitalopramACTIVE MOIETY4O4S742ANYESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]8
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]8
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]8
HypromellosesINACTIVE INGREDIENT3NXW29V3WOESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]8
Magnesium StearateINACTIVE INGREDIENT70097M6I30ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]8
Polyethylene Glycol 400INACTIVE INGREDIENTB697894SGQESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]8
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]8
TalcINACTIVE INGREDIENT7SEV7J4R1UESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]8
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-281ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]13Current NDC, Legacy NDC, 5 package rows20240206_2db02476-325f-ee47-a7e5-b5aed56c364c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN2db02476-325f-ee47-a7e5-b5aed56c364c14
351250escitalopram oxalate 20 MG Oral TabletPSN2db02476-325f-ee47-a7e5-b5aed56c364c14
351249escitalopram oxalate 5 MG Oral TabletPSN2db02476-325f-ee47-a7e5-b5aed56c364c14
349332escitalopram 10 MG Oral TabletSCD2db02476-325f-ee47-a7e5-b5aed56c364c14
351250escitalopram 20 MG Oral TabletSCD2db02476-325f-ee47-a7e5-b5aed56c364c14
351249escitalopram 5 MG Oral TabletSCD2db02476-325f-ee47-a7e5-b5aed56c364c14
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY2db02476-325f-ee47-a7e5-b5aed56c364c14
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY2db02476-325f-ee47-a7e5-b5aed56c364c14
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY2db02476-325f-ee47-a7e5-b5aed56c364c14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59746-281-0159746028101100 TABLET, FILM COATED in 1 BOTTLE (59746-281-01) 2024-01-010000-00-00NoNoCurrent
59746-281-0559746028105500 TABLET, FILM COATED in 1 BOTTLE (59746-281-05) 2024-01-010000-00-00NoNoCurrent
59746-281-10597460281101000 TABLET, FILM COATED in 1 BOTTLE (59746-281-10) 2024-01-010000-00-00NoNoCurrent
59746-281-305974602813030 TABLET, FILM COATED in 1 BOTTLE (59746-281-30) 2024-01-010000-00-00NoNoCurrent
59746-281-905974602819090 TABLET, FILM COATED in 1 BOTTLE (59746-281-90) 2024-01-010000-00-00NoNoCurrent