FDA.reportPublic FDA data

Escitalopram

Product NDC
65862-373
11-digit product format
658620373
Labeler code
65862
Product ID
65862-373_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
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
Rxcui349332, 351249, 351250

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-373-01Escitalopram100 in 1 BOTTLETABLET, FILM COATED10020
65862-373-05Escitalopram500 in 1 BOTTLETABLET, FILM COATED50020
65862-373-10Escitalopram10 in 1 BLISTER PACKTABLET, FILM COATED1020
65862-373-10Escitalopram10 in 1 CARTONTABLET, FILM COATED1020
65862-373-19Escitalopram10000 in 1 BOTTLETABLET, FILM COATED1000020
65862-373-30Escitalopram30 in 1 BOTTLETABLET, FILM COATED3020
65862-373-90Escitalopram90 in 1 BOTTLETABLET, FILM COATED9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-373-01EA - Each65862-3731392be3e-abd5-4c05-949b-294eefbd87da12013-02-13
65862-373-05EA - Each65862-3732dcb6b4f-aff5-4159-99c9-66419bc30f2212013-02-13

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-373ESCITALOPRAM (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
351249escitalopram oxalate 5 MG Oral TabletPSNee5963ad-3b53-48e5-b7a9-b13af5740ef1104
351249escitalopram 5 MG Oral TabletSCDee5963ad-3b53-48e5-b7a9-b13af5740ef1104
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSYee5963ad-3b53-48e5-b7a9-b13af5740ef1104
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 TabletPSNb29ae169-d60b-464a-9763-f1d8d9e0598d4
351249escitalopram oxalate 5 MG Oral TabletPSNb29ae169-d60b-464a-9763-f1d8d9e0598d4
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 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
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
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
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY2957a003-7714-4e16-aeca-623fd6c5d7022
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY2957a003-7714-4e16-aeca-623fd6c5d7022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-373-0165862037301100 TABLET, FILM COATED in 1 BOTTLE (65862-373-01) 2012-09-110000-00-00NoNoCurrent
65862-373-0565862037305500 TABLET, FILM COATED in 1 BOTTLE (65862-373-05) 2012-09-110000-00-00NoNoCurrent
65862-373-106586203731010 BLISTER PACK in 1 CARTON (65862-373-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2012-09-110000-00-00NoNoCurrent
65862-373-196586203731910000 TABLET, FILM COATED in 1 BOTTLE (65862-373-19) 2012-09-110000-00-00NoNoCurrent
65862-373-306586203733030 TABLET, FILM COATED in 1 BOTTLE (65862-373-30) 2012-09-110000-00-00NoNoCurrent
65862-373-906586203739090 TABLET, FILM COATED in 1 BOTTLE (65862-373-90) 2012-09-110000-00-00NoNoCurrent