FDA.reportPublic FDA data

Escitalopram Oxalate

Product NDC
69097-847
11-digit product format
690970847
Labeler code
69097
Product ID
69097-847_7e44336f-9692-42ff-af45-f98edd0c803c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA078604
Marketing category
ANDA
Marketing start
2016-06-16
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Escitalopram Oxalate
Listing expiration
2026-12-31

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
69097-847-02Escitalopram Oxalate30 in 1 BOTTLETABLET, FILM COATED3012
69097-847-05Escitalopram Oxalate90 in 1 BOTTLETABLET, FILM COATED9012
69097-847-07Escitalopram Oxalate100 in 1 BOTTLETABLET, FILM COATED10012
69097-847-12Escitalopram Oxalate500 in 1 BOTTLETABLET, FILM COATED50012
69097-847-15Escitalopram Oxalate1000 in 1 BOTTLETABLET, FILM COATED100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-847-05EA - Each69097-847db76407a-454e-4a0d-a70c-7730955e933412016-07-19
69097-847-15EA - Each69097-847c4cb7627-cf1e-483f-8ce0-94afb6118b5a12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-847ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [CIPLA USA INC.]11Current NDC, Legacy NDC, 5 package rows20240831_31ce0b82-58fe-44f3-8887-c55d8df1b773.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN31ce0b82-58fe-44f3-8887-c55d8df1b77312
351250escitalopram oxalate 20 MG Oral TabletPSN31ce0b82-58fe-44f3-8887-c55d8df1b77312
351249escitalopram oxalate 5 MG Oral TabletPSN31ce0b82-58fe-44f3-8887-c55d8df1b77312
349332escitalopram 10 MG Oral TabletSCD31ce0b82-58fe-44f3-8887-c55d8df1b77312
351250escitalopram 20 MG Oral TabletSCD31ce0b82-58fe-44f3-8887-c55d8df1b77312
351249escitalopram 5 MG Oral TabletSCD31ce0b82-58fe-44f3-8887-c55d8df1b77312
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY31ce0b82-58fe-44f3-8887-c55d8df1b77312
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY31ce0b82-58fe-44f3-8887-c55d8df1b77312
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY31ce0b82-58fe-44f3-8887-c55d8df1b77312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69097-847-026909708470230 TABLET, FILM COATED in 1 BOTTLE (69097-847-02) 2016-06-160000-00-00NoNoCurrent
69097-847-056909708470590 TABLET, FILM COATED in 1 BOTTLE (69097-847-05) 2016-06-160000-00-00NoNoCurrent
69097-847-0769097084707100 TABLET, FILM COATED in 1 BOTTLE (69097-847-07) 2016-06-160000-00-00NoNoCurrent
69097-847-1269097084712500 TABLET, FILM COATED in 1 BOTTLE (69097-847-12) 2016-06-160000-00-00NoNoCurrent
69097-847-15690970847151000 TABLET, FILM COATED in 1 BOTTLE (69097-847-15) 2016-06-160000-00-00NoNoCurrent