FDA.reportPublic FDA data

Escitalopram

Product NDC
16729-168
11-digit product format
167290168
Labeler code
16729
Product ID
16729-168_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
2013-03-05
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
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
16729-168-01Escitalopram100 in 1 BOTTLETABLET, FILM COATED10015
16729-168-10Escitalopram30 in 1 BOTTLETABLET, FILM COATED3015
16729-168-16Escitalopram500 in 1 BOTTLETABLET, FILM COATED50015
16729-168-17Escitalopram1000 in 1 BOTTLETABLET, FILM COATED100015
16729-168-43Escitalopram10 in 1 BLISTER PACKTABLET, FILM COATED1015
16729-168-43Escitalopram10 in 1 CARTONTABLET, FILM COATED1015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-168-01EA - Each16729-16807a38b1d-23ec-401f-a1a9-76e4b137df6212013-04-01
16729-168-17EA - Each16729-168459040e0-0bbc-428b-b6b6-7cd660d7e5c312013-04-01

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
16729-168ESCITALOPRAM 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
351249escitalopram oxalate 5 MG Oral TabletPSN43eb9e4f-1a46-46f7-9e9d-43e866963b37104
351249escitalopram 5 MG Oral TabletSCD43eb9e4f-1a46-46f7-9e9d-43e866963b37104
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY43eb9e4f-1a46-46f7-9e9d-43e866963b37104
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
351249escitalopram oxalate 5 MG Oral TabletPSN963bcccc-0926-fe8e-e053-2a95a90a00317
351249escitalopram 5 MG Oral TabletSCD963bcccc-0926-fe8e-e053-2a95a90a00317
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY963bcccc-0926-fe8e-e053-2a95a90a00317
351249escitalopram oxalate 5 MG Oral TabletPSNf1b7c316-a499-4060-89e8-c5210f331ef56
351249escitalopram 5 MG Oral TabletSCDf1b7c316-a499-4060-89e8-c5210f331ef56
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSYf1b7c316-a499-4060-89e8-c5210f331ef56
351249escitalopram oxalate 5 MG Oral TabletPSNda7feb56-5f5a-7487-e053-2995a90a119e4
351249escitalopram 5 MG Oral TabletSCDda7feb56-5f5a-7487-e053-2995a90a119e4
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSYda7feb56-5f5a-7487-e053-2995a90a119e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-168-0116729016801100 TABLET, FILM COATED in 1 BOTTLE (16729-168-01) 2013-03-050000-00-00NoNoCurrent
16729-168-101672901681030 in 1 BOTTLEHistorical
16729-168-1616729016816500 in 1 BOTTLEHistorical
16729-168-17167290168171000 TABLET, FILM COATED in 1 BOTTLE (16729-168-17) 2014-07-230000-00-00NoNoCurrent
16729-168-431672901684310 in 1 BLISTER PACKHistorical