FDA.reportPublic FDA data

Escitalopram

Product NDC
65862-375
11-digit product format
658620375
Labeler code
65862
Product ID
65862-375_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
20 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 OXALATE20 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
65862-375-01Escitalopram100 in 1 BOTTLETABLET, FILM COATED10020
65862-375-05Escitalopram500 in 1 BOTTLETABLET, FILM COATED50020
65862-375-10Escitalopram10 in 1 CARTONTABLET, FILM COATED1020
65862-375-10Escitalopram10 in 1 BLISTER PACKTABLET, FILM COATED1020
65862-375-30Escitalopram30 in 1 BOTTLETABLET, FILM COATED3020
65862-375-39Escitalopram3000 in 1 BOTTLETABLET, FILM COATED300020
65862-375-90Escitalopram90 in 1 BOTTLETABLET, FILM COATED9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-375-01EA - Each65862-3756cfefa1a-6785-4095-9952-585f5e5d972112013-02-13
65862-375-05EA - Each65862-3751ed6910d-a40e-4098-b001-d0490b79fb3912013-02-13

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
65862-375ESCITALOPRAM (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
351250escitalopram oxalate 20 MG Oral TabletPSN517a551a-6f60-4b8d-9341-63a41baff12d21
351250escitalopram 20 MG Oral TabletSCD517a551a-6f60-4b8d-9341-63a41baff12d21
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY517a551a-6f60-4b8d-9341-63a41baff12d21
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
351250escitalopram oxalate 20 MG Oral TabletPSN52df055d-b1c8-4de2-8545-ef08b5bf9c395
351250escitalopram 20 MG Oral TabletSCD52df055d-b1c8-4de2-8545-ef08b5bf9c395
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY52df055d-b1c8-4de2-8545-ef08b5bf9c395
351250escitalopram oxalate 20 MG Oral TabletPSNf6ca64ec-68ff-e1ea-e053-6294a90ae0f84
351250escitalopram 20 MG Oral TabletSCDf6ca64ec-68ff-e1ea-e053-6294a90ae0f84
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYf6ca64ec-68ff-e1ea-e053-6294a90ae0f84
349332escitalopram oxalate 10 MG Oral TabletPSN2957a003-7714-4e16-aeca-623fd6c5d7022
351250escitalopram oxalate 20 MG Oral TabletPSN2957a003-7714-4e16-aeca-623fd6c5d7022
351250escitalopram oxalate 20 MG Oral TabletPSNd31fd978-0700-2188-e053-2a95a90a63542
351250escitalopram oxalate 20 MG Oral TabletPSNb2f51151-2cce-4036-8a5e-9fb6a9a6fcc02
351249escitalopram oxalate 5 MG Oral TabletPSN2957a003-7714-4e16-aeca-623fd6c5d7022
349332escitalopram 10 MG Oral TabletSCD2957a003-7714-4e16-aeca-623fd6c5d7022
351250escitalopram 20 MG Oral TabletSCDb2f51151-2cce-4036-8a5e-9fb6a9a6fcc02
351250escitalopram 20 MG Oral TabletSCD2957a003-7714-4e16-aeca-623fd6c5d7022
351250escitalopram 20 MG Oral TabletSCDd31fd978-0700-2188-e053-2a95a90a63542
351249escitalopram 5 MG Oral TabletSCD2957a003-7714-4e16-aeca-623fd6c5d7022
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY2957a003-7714-4e16-aeca-623fd6c5d7022
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYd31fd978-0700-2188-e053-2a95a90a63542
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY2957a003-7714-4e16-aeca-623fd6c5d7022
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYb2f51151-2cce-4036-8a5e-9fb6a9a6fcc02
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY2957a003-7714-4e16-aeca-623fd6c5d7022
351250escitalopram oxalate 20 MG Oral TabletPSNac9ede0c-7912-4e7d-83b3-964feee612151
351250escitalopram oxalate 20 MG Oral TabletPSN10b25a10-c5e7-479b-a9f5-7eeafd8023231
351250escitalopram oxalate 20 MG Oral TabletPSN09945404-e4cf-6269-e063-6294a90a5b8d1
351250escitalopram 20 MG Oral TabletSCDac9ede0c-7912-4e7d-83b3-964feee612151
351250escitalopram 20 MG Oral TabletSCD10b25a10-c5e7-479b-a9f5-7eeafd8023231
351250escitalopram 20 MG Oral TabletSCD09945404-e4cf-6269-e063-6294a90a5b8d1
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYac9ede0c-7912-4e7d-83b3-964feee612151
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY10b25a10-c5e7-479b-a9f5-7eeafd8023231
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY09945404-e4cf-6269-e063-6294a90a5b8d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-375-0165862037501100 TABLET, FILM COATED in 1 BOTTLE (65862-375-01) 2012-09-110000-00-00NoNoCurrent
65862-375-0565862037505500 TABLET, FILM COATED in 1 BOTTLE (65862-375-05) 2012-09-110000-00-00NoNoCurrent
65862-375-106586203751010 BLISTER PACK in 1 CARTON (65862-375-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2012-09-110000-00-00NoNoCurrent
65862-375-306586203753030 TABLET, FILM COATED in 1 BOTTLE (65862-375-30) 2012-09-110000-00-00NoNoCurrent
65862-375-39658620375393000 TABLET, FILM COATED in 1 BOTTLE (65862-375-39) 2012-09-110000-00-00NoNoCurrent
65862-375-906586203759090 TABLET, FILM COATED in 1 BOTTLE (65862-375-90) 2012-09-110000-00-00NoNoCurrent