FDA.reportPublic FDA data

Escitalopram

Product NDC
65862-374
11-digit product format
658620374
Labeler code
65862
Product ID
65862-374_eee33c81-29aa-4666-af3b-fef9c3de6107
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram Oxalate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA090432
Marketing category
ANDA
Marketing start
2012-09-11
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, 351249, 351250

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615Product name620170718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-374-01Escitalopram100 in 1 BOTTLETABLET, FILM COATED10020
65862-374-05Escitalopram500 in 1 BOTTLETABLET, FILM COATED50020
65862-374-10Escitalopram10 in 1 CARTONTABLET, FILM COATED1020
65862-374-10Escitalopram10 in 1 BLISTER PACKTABLET, FILM COATED1020
65862-374-30Escitalopram30 in 1 BOTTLETABLET, FILM COATED3020
65862-374-59Escitalopram5000 in 1 BOTTLETABLET, FILM COATED500020
65862-374-90Escitalopram90 in 1 BOTTLETABLET, FILM COATED9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-374-01EA - Each65862-37459fa1e37-1093-472a-b407-63de5a9d0c0f12013-02-13
65862-374-05EA - Each65862-3743718049d-8f41-42fd-a6b7-c6a5b57bdb7312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESCITALOPRAM OXALATEACTIVE INGREDIENT5U85DBW7LOESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
ESCITALOPRAMACTIVE MOIETY4O4S742ANYESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
TALCINACTIVE INGREDIENT7SEV7J4R1UESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
ESCITALOPRAM OXALATEACTIVE INGREDIENT5U85DBW7LOESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
ESCITALOPRAMACTIVE MOIETY4O4S742ANYESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
TALCINACTIVE INGREDIENT7SEV7J4R1UESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-374ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]19Current NDC, Legacy NDC, 7 package rows20241004_d5fbc8ce-bd41-4bd0-b413-0dea97e596c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN85fbcce8-a870-4f04-8a0e-a12e46eed3cf28
349332escitalopram 10 MG Oral TabletSCD85fbcce8-a870-4f04-8a0e-a12e46eed3cf28
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY85fbcce8-a870-4f04-8a0e-a12e46eed3cf28
349332escitalopram oxalate 10 MG Oral TabletPSNd5fbc8ce-bd41-4bd0-b413-0dea97e596c320
351250escitalopram oxalate 20 MG Oral TabletPSNd5fbc8ce-bd41-4bd0-b413-0dea97e596c320
351249escitalopram oxalate 5 MG Oral TabletPSNd5fbc8ce-bd41-4bd0-b413-0dea97e596c320
349332escitalopram 10 MG Oral TabletSCDd5fbc8ce-bd41-4bd0-b413-0dea97e596c320
351250escitalopram 20 MG Oral TabletSCDd5fbc8ce-bd41-4bd0-b413-0dea97e596c320
351249escitalopram 5 MG Oral TabletSCDd5fbc8ce-bd41-4bd0-b413-0dea97e596c320
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYd5fbc8ce-bd41-4bd0-b413-0dea97e596c320
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYd5fbc8ce-bd41-4bd0-b413-0dea97e596c320
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSYd5fbc8ce-bd41-4bd0-b413-0dea97e596c320
349332escitalopram oxalate 10 MG Oral TabletPSN3019a647-9bcf-48cf-928c-0467f9b921a812
351250escitalopram oxalate 20 MG Oral TabletPSN3019a647-9bcf-48cf-928c-0467f9b921a812
349332escitalopram 10 MG Oral TabletSCD3019a647-9bcf-48cf-928c-0467f9b921a812
351250escitalopram 20 MG Oral TabletSCD3019a647-9bcf-48cf-928c-0467f9b921a812
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY3019a647-9bcf-48cf-928c-0467f9b921a812
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY3019a647-9bcf-48cf-928c-0467f9b921a812
349332escitalopram oxalate 10 MG Oral TabletPSNb85ef018-0217-4ddf-885d-206acc0a5f845
349332escitalopram 10 MG Oral TabletSCDb85ef018-0217-4ddf-885d-206acc0a5f845
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYb85ef018-0217-4ddf-885d-206acc0a5f845
349332escitalopram oxalate 10 MG Oral TabletPSN2d0b4839-e4d1-4e0e-9dc0-ba821f2664724
349332escitalopram oxalate 10 MG Oral TabletPSNb29ae169-d60b-464a-9763-f1d8d9e0598d4
351249escitalopram oxalate 5 MG Oral TabletPSNb29ae169-d60b-464a-9763-f1d8d9e0598d4
349332escitalopram 10 MG Oral TabletSCD2d0b4839-e4d1-4e0e-9dc0-ba821f2664724
349332escitalopram 10 MG Oral TabletSCDb29ae169-d60b-464a-9763-f1d8d9e0598d4
351249escitalopram 5 MG Oral TabletSCDb29ae169-d60b-464a-9763-f1d8d9e0598d4
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY2d0b4839-e4d1-4e0e-9dc0-ba821f2664724
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYb29ae169-d60b-464a-9763-f1d8d9e0598d4
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSYb29ae169-d60b-464a-9763-f1d8d9e0598d4
349332escitalopram oxalate 10 MG Oral TabletPSN2957a003-7714-4e16-aeca-623fd6c5d7022
349332escitalopram oxalate 10 MG Oral TabletPSN138f8703-2f13-6d07-e063-6394a90a44132
351250escitalopram oxalate 20 MG Oral TabletPSN2957a003-7714-4e16-aeca-623fd6c5d7022
351249escitalopram oxalate 5 MG Oral TabletPSN2957a003-7714-4e16-aeca-623fd6c5d7022
349332escitalopram 10 MG Oral TabletSCD2957a003-7714-4e16-aeca-623fd6c5d7022
349332escitalopram 10 MG Oral TabletSCD138f8703-2f13-6d07-e063-6394a90a44132
351250escitalopram 20 MG Oral TabletSCD2957a003-7714-4e16-aeca-623fd6c5d7022
351249escitalopram 5 MG Oral TabletSCD2957a003-7714-4e16-aeca-623fd6c5d7022
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY2957a003-7714-4e16-aeca-623fd6c5d7022
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY138f8703-2f13-6d07-e063-6394a90a44132
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY2957a003-7714-4e16-aeca-623fd6c5d7022
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY2957a003-7714-4e16-aeca-623fd6c5d7022
349332escitalopram oxalate 10 MG Oral TabletPSN07c7a6b2-44cb-4808-9892-496e80f1d9c21
349332escitalopram 10 MG Oral TabletSCD07c7a6b2-44cb-4808-9892-496e80f1d9c21
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY07c7a6b2-44cb-4808-9892-496e80f1d9c21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-374-0165862037401100 TABLET, FILM COATED in 1 BOTTLE (65862-374-01) 2012-09-110000-00-00NoNoCurrent
65862-374-0565862037405500 TABLET, FILM COATED in 1 BOTTLE (65862-374-05) 2012-09-110000-00-00NoNoCurrent
65862-374-106586203741010 BLISTER PACK in 1 CARTON (65862-374-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2012-09-110000-00-00NoNoCurrent
65862-374-306586203743030 TABLET, FILM COATED in 1 BOTTLE (65862-374-30) 2012-09-110000-00-00NoNoCurrent
65862-374-59658620374595000 TABLET, FILM COATED in 1 BOTTLE (65862-374-59) 2012-09-110000-00-00NoNoCurrent
65862-374-906586203749090 TABLET, FILM COATED in 1 BOTTLE (65862-374-90) 2012-09-110000-00-00NoNoCurrent