FDA.reportPublic FDA data

ESCITALOPRAM

Product NDC
61919-652
11-digit product format
619190652
Labeler code
61919
Product ID
61919-652_f2152c16-6cf3-40e5-e053-2995a90aeba3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESCITALOPRAM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DirectRX
Application
ANDA202389
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
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
2024-12-31
Current FDA listing
Historical FDA.report record

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
61919-652-202025-01-30C16284748780-12cef2736-7bac-d83d-e063-dadaa90ab31fESCITALOPRAM
61919-652-302025-01-30C16284748780-12cef2736-7bac-d83d-e063-dadaa90ab31fESCITALOPRAM
61919-652-602025-01-30C16284748780-12cef2736-7bac-d83d-e063-dadaa90ab31fESCITALOPRAM
61919-652-902025-01-30C16284748780-12cef2736-7bac-d83d-e063-dadaa90ab31fESCITALOPRAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-652-20ESCITALOPRAM20 in 1 BOTTLETABLET, FILM COATED206
61919-652-30ESCITALOPRAM30 in 1 BOTTLETABLET, FILM COATED306
61919-652-60ESCITALOPRAM60 in 1 BOTTLETABLET, FILM COATED606
61919-652-90ESCITALOPRAM90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-652-30EA - Each61919-652083be0f9-8f1e-4134-b053-8ecc52f07e8312016-09-02
61919-652-60EA - Each61919-652bd863b25-c88b-43c3-ad54-89273df2652112019-11-12
61919-652-90EA - Each61919-65279cda95c-9ab1-4d04-91cd-765bd44e5cf312021-07-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESCITALOPRAM OXALATEACTIVE INGREDIENT5U85DBW7LOESCITALOPRAM TABLET, COATED [DIRECTRX]1
ESCITALOPRAMACTIVE MOIETY4O4S742ANYESCITALOPRAM TABLET, COATED [DIRECTRX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESCITALOPRAM TABLET, COATED [DIRECTRX]1
HYPROMELLOSE 2910 (15000 MPA.S)INACTIVE INGREDIENT288VBX44JCESCITALOPRAM TABLET, COATED [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESCITALOPRAM TABLET, COATED [DIRECTRX]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQESCITALOPRAM TABLET, COATED [DIRECTRX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ESCITALOPRAM TABLET, COATED [DIRECTRX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESCITALOPRAM TABLET, COATED [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-652ESCITALOPRAM TABLET, FILM COATED [DIRECTRX]6Legacy NDC, 4 package rows20230511_6dac216a-62d6-4613-8ebe-a2920b4a1799.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351250escitalopram oxalate 20 MG Oral TabletPSN6dac216a-62d6-4613-8ebe-a2920b4a17996
351250escitalopram 20 MG Oral TabletSCD6dac216a-62d6-4613-8ebe-a2920b4a17996
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY6dac216a-62d6-4613-8ebe-a2920b4a17996

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-652-206191906522020 TABLET, FILM COATED in 1 BOTTLE (61919-652-20) 2015-01-010000-00-00NoNoCurrent
61919-652-306191906523030 TABLET, FILM COATED in 1 BOTTLE (61919-652-30) 2015-01-010000-00-00NoNoCurrent
61919-652-606191906526060 TABLET, FILM COATED in 1 BOTTLE (61919-652-60) 2015-01-010000-00-00NoNoCurrent
61919-652-906191906529090 TABLET, FILM COATED in 1 BOTTLE (61919-652-90) 2015-01-010000-00-00NoNoCurrent