FDA.reportPublic FDA data

Escitalopram

Product NDC
16729-169
11-digit product format
167290169
Labeler code
16729
Product ID
16729-169_411f7056-e508-9e1b-e063-6294a90a6396
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA202389
Marketing category
ANDA
Marketing start
2013-03-19
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESCITALOPRAM OXALATE10 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
16729-169-01Escitalopram100 in 1 BOTTLETABLET, FILM COATED10015
16729-169-10Escitalopram30 in 1 BOTTLETABLET, FILM COATED3015
16729-169-16Escitalopram500 in 1 BOTTLETABLET, FILM COATED50015
16729-169-17Escitalopram1000 in 1 BOTTLETABLET, FILM COATED100015
16729-169-43Escitalopram10 in 1 BLISTER PACKTABLET, FILM COATED1015
16729-169-43Escitalopram10 in 1 CARTONTABLET, FILM COATED1015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-169-01EA - Each16729-1696d5de99a-325f-4b71-bdd2-7f696aaa576312013-04-01
16729-169-17EA - Each16729-169e8f2db4c-1795-498e-bec8-ae82389d113712013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESCITALOPRAM OXALATEACTIVE INGREDIENT5U85DBW7LOESCITALOPRAM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6
ESCITALOPRAMACTIVE MOIETY4O4S742ANYESCITALOPRAM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESCITALOPRAM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6
HYPROMELLOSE 2910 (15000 MPA.S)INACTIVE INGREDIENT288VBX44JCESCITALOPRAM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESCITALOPRAM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQESCITALOPRAM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ESCITALOPRAM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESCITALOPRAM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-169ESCITALOPRAM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]14Current NDC, Legacy NDC, 6 package rows20241206_84b2028d-eff4-434d-b71e-6a3c0812f625.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN4966fd83-ee96-4f87-beb1-dd40d70de445104
349332escitalopram 10 MG Oral TabletSCD4966fd83-ee96-4f87-beb1-dd40d70de445104
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY4966fd83-ee96-4f87-beb1-dd40d70de445104
349332escitalopram oxalate 10 MG Oral TabletPSN83510549-bd47-4969-aba0-c149a0fbb7f317
349332escitalopram 10 MG Oral TabletSCD83510549-bd47-4969-aba0-c149a0fbb7f317
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY83510549-bd47-4969-aba0-c149a0fbb7f317
349332escitalopram oxalate 10 MG Oral TabletPSN84b2028d-eff4-434d-b71e-6a3c0812f62515
351250escitalopram oxalate 20 MG Oral TabletPSN84b2028d-eff4-434d-b71e-6a3c0812f62515
351249escitalopram oxalate 5 MG Oral TabletPSN84b2028d-eff4-434d-b71e-6a3c0812f62515
349332escitalopram 10 MG Oral TabletSCD84b2028d-eff4-434d-b71e-6a3c0812f62515
351250escitalopram 20 MG Oral TabletSCD84b2028d-eff4-434d-b71e-6a3c0812f62515
351249escitalopram 5 MG Oral TabletSCD84b2028d-eff4-434d-b71e-6a3c0812f62515
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY84b2028d-eff4-434d-b71e-6a3c0812f62515
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY84b2028d-eff4-434d-b71e-6a3c0812f62515
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY84b2028d-eff4-434d-b71e-6a3c0812f62515
349332escitalopram oxalate 10 MG Oral TabletPSN7716abd2-5378-4281-8767-57ce890be1d75
349332escitalopram oxalate 10 MG Oral TabletPSN16a07596-2a89-4897-a829-529452ceb1e85
351250escitalopram oxalate 20 MG Oral TabletPSN7716abd2-5378-4281-8767-57ce890be1d75
349332escitalopram 10 MG Oral TabletSCD7716abd2-5378-4281-8767-57ce890be1d75
349332escitalopram 10 MG Oral TabletSCD16a07596-2a89-4897-a829-529452ceb1e85
351250escitalopram 20 MG Oral TabletSCD7716abd2-5378-4281-8767-57ce890be1d75
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY7716abd2-5378-4281-8767-57ce890be1d75
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY16a07596-2a89-4897-a829-529452ceb1e85
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY7716abd2-5378-4281-8767-57ce890be1d75
349332escitalopram oxalate 10 MG Oral TabletPSNd9ba6c65-22bd-10c4-e053-2995a90ada2e4
349332escitalopram oxalate 10 MG Oral TabletPSNc9f52332-8616-19d8-e053-2995a90ad7534
349332escitalopram 10 MG Oral TabletSCDc9f52332-8616-19d8-e053-2995a90ad7534
349332escitalopram 10 MG Oral TabletSCDd9ba6c65-22bd-10c4-e053-2995a90ada2e4
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYc9f52332-8616-19d8-e053-2995a90ad7534
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYd9ba6c65-22bd-10c4-e053-2995a90ada2e4
349332escitalopram oxalate 10 MG Oral TabletPSN77f99a86-83c0-016b-e053-2991aa0a43623
349332escitalopram oxalate 10 MG Oral TabletPSN4ecd48c4-482a-5681-e054-00144ff8d46c3
349332escitalopram 10 MG Oral TabletSCD77f99a86-83c0-016b-e053-2991aa0a43623
349332escitalopram 10 MG Oral TabletSCD4ecd48c4-482a-5681-e054-00144ff8d46c3
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY77f99a86-83c0-016b-e053-2991aa0a43623
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY4ecd48c4-482a-5681-e054-00144ff8d46c3
349332escitalopram oxalate 10 MG Oral TabletPSN2fb28a40-037a-49a0-b418-6c6841885cf42
349332escitalopram 10 MG Oral TabletSCD2fb28a40-037a-49a0-b418-6c6841885cf42
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY2fb28a40-037a-49a0-b418-6c6841885cf42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-169-0116729016901100 TABLET, FILM COATED in 1 BOTTLE (16729-169-01) 2013-03-190000-00-00NoNoCurrent
16729-169-101672901691030 in 1 BOTTLEHistorical
16729-169-1616729016916500 in 1 BOTTLEHistorical
16729-169-17167290169171000 TABLET, FILM COATED in 1 BOTTLE (16729-169-17) 2013-11-120000-00-00NoNoCurrent
16729-169-431672901694310 in 1 BLISTER PACKHistorical