FDA.reportPublic FDA data

ESCITALOPRAM OXALATE

Product NDC
61919-139
11-digit product format
619190139
Labeler code
61919
Product ID
61919-139_d929b068-4c88-0c5c-e053-2995a90ab99a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESCITALOPRAM OXALATE
Dosage form
TABLET
Route
ORAL
Labeler
Direct Rx
Application
ANDA090939
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
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
2023-12-31
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
61919-139-302025-01-30C16284748780-19d75b9d0-a7e0-f424-e053-dadaa90a57ceESCITALOPRAM OXALATE
61919-139-602025-01-30C16284748780-19d75b9d0-a7e0-f424-e053-dadaa90a57ceESCITALOPRAM OXALATE
61919-139-902025-01-30C16284748780-19d75b9d0-a7e0-f424-e053-dadaa90a57ceESCITALOPRAM OXALATE
61919-139-302020-07-23C16284748780-19d75b9d0-a7e0-f424-e053-dadaa90a57ceESCITALOPRAM OXALATE
61919-139-602020-07-23C16284748780-19d75b9d0-a7e0-f424-e053-dadaa90a57ceESCITALOPRAM OXALATE
61919-139-902020-07-23C16284748780-19d75b9d0-a7e0-f424-e053-dadaa90a57ceESCITALOPRAM OXALATE
61919-139-302020-01-31C16284748780-19d75b9d0-a7e0-f424-e053-dadaa90a57ceESCITALOPRAM OXALATE
61919-139-602020-01-31C16284748780-19d75b9d0-a7e0-f424-e053-dadaa90a57ceESCITALOPRAM OXALATE
61919-139-902020-01-31C16284748780-19d75b9d0-a7e0-f424-e053-dadaa90a57ceESCITALOPRAM OXALATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-139-30ESCITALOPRAM OXALATE30 in 1 BOTTLETABLET307
61919-139-60ESCITALOPRAM OXALATE60 in 1 BOTTLETABLET607
61919-139-90ESCITALOPRAM OXALATE90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-139-30EA - Each61919-13951d434ef-e122-49ec-98e5-08be458fb08a12014-05-02
61919-139-60EA - Each61919-13947f4ff96-a8a6-4c83-ab9d-c55ba4fa96f612016-04-04
61919-139-90EA - Each61919-1394ef53b53-bf9d-4919-b8d9-a3807dea88c512015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESCITALOPRAM OXALATEACTIVE INGREDIENT5U85DBW7LOESCITALOPRAM OXALATE TABLET [DIRECT RX]3
ESCITALOPRAMACTIVE MOIETY4O4S742ANYESCITALOPRAM OXALATE TABLET [DIRECT RX]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESCITALOPRAM OXALATE TABLET [DIRECT RX]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ESCITALOPRAM OXALATE TABLET [DIRECT RX]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ESCITALOPRAM OXALATE TABLET [DIRECT RX]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ESCITALOPRAM OXALATE TABLET [DIRECT RX]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESCITALOPRAM OXALATE TABLET [DIRECT RX]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQESCITALOPRAM OXALATE TABLET [DIRECT RX]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EESCITALOPRAM OXALATE TABLET [DIRECT RX]3
TALCINACTIVE INGREDIENT7SEV7J4R1UESCITALOPRAM OXALATE TABLET [DIRECT RX]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESCITALOPRAM OXALATE TABLET [DIRECT RX]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-139ESCITALOPRAM OXALATE TABLET [DIRECT RX]7Legacy NDC, 3 package rows20220303_ce8be2b4-1525-4864-99c1-9e24815957dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSNce8be2b4-1525-4864-99c1-9e24815957dc7
349332escitalopram 10 MG Oral TabletSCDce8be2b4-1525-4864-99c1-9e24815957dc7
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYce8be2b4-1525-4864-99c1-9e24815957dc7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-139-306191901393030 TABLET in 1 BOTTLE (61919-139-30) 30 tablet2015-01-010000-00-00NoNoCurrent
61919-139-606191901396060 TABLET in 1 BOTTLE (61919-139-60) 60 tablet2015-01-010000-00-00NoNoCurrent
61919-139-906191901399090 TABLET in 1 BOTTLE (61919-139-90) 90 tablet2015-01-010000-00-00NoNoCurrent