FDA.reportPublic FDA data

Escitalopram

Product NDC
16729-170
11-digit product format
167290170
Labeler code
16729
Product ID
16729-170_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
2013-03-21
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
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 OXALATE20 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
16729-170-01Escitalopram100 in 1 BOTTLETABLET, FILM COATED10015
16729-170-10Escitalopram30 in 1 BOTTLETABLET, FILM COATED3015
16729-170-16Escitalopram500 in 1 BOTTLETABLET, FILM COATED50015
16729-170-17Escitalopram1000 in 1 BOTTLETABLET, FILM COATED100015
16729-170-43Escitalopram10 in 1 CARTONTABLET, FILM COATED1015
16729-170-43Escitalopram10 in 1 BLISTER PACKTABLET, FILM COATED1015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-170-01EA - Each16729-1703de0b540-16fc-4bd7-97b4-14949d9d7a3312013-04-01
16729-170-17EA - Each16729-170b984dcd8-bfdb-44af-8049-0d3b9b49e27d12013-04-01

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
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
16729-170ESCITALOPRAM 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
351250escitalopram oxalate 20 MG Oral TabletPSN2d125ea4-5430-5b4e-e054-00144ff88e8825
351250escitalopram 20 MG Oral TabletSCD2d125ea4-5430-5b4e-e054-00144ff88e8825
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY2d125ea4-5430-5b4e-e054-00144ff88e8825
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
351250escitalopram oxalate 20 MG Oral TabletPSNe0eff3a7-475a-471a-b7c5-256992c5ec1e8
351250escitalopram 20 MG Oral TabletSCDe0eff3a7-475a-471a-b7c5-256992c5ec1e8
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYe0eff3a7-475a-471a-b7c5-256992c5ec1e8
351250escitalopram oxalate 20 MG Oral TabletPSNd143ec01-9445-42d5-a259-b0b5a7f9445f7
351250escitalopram 20 MG Oral TabletSCDd143ec01-9445-42d5-a259-b0b5a7f9445f7
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYd143ec01-9445-42d5-a259-b0b5a7f9445f7
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
349332escitalopram oxalate 10 MG Oral TabletPSN7716abd2-5378-4281-8767-57ce890be1d75
351250escitalopram oxalate 20 MG Oral TabletPSN7716abd2-5378-4281-8767-57ce890be1d75
351250escitalopram oxalate 20 MG Oral TabletPSN4a645652-ae1f-3811-e054-00144ff8d46c5
349332escitalopram 10 MG Oral TabletSCD7716abd2-5378-4281-8767-57ce890be1d75
351250escitalopram 20 MG Oral TabletSCD7716abd2-5378-4281-8767-57ce890be1d75
351250escitalopram 20 MG Oral TabletSCD4a645652-ae1f-3811-e054-00144ff8d46c5
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY7716abd2-5378-4281-8767-57ce890be1d75
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY7716abd2-5378-4281-8767-57ce890be1d75
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY4a645652-ae1f-3811-e054-00144ff8d46c5
351250escitalopram oxalate 20 MG Oral TabletPSNdabf8bc0-5de6-edce-e053-2995a90a73c94
351250escitalopram oxalate 20 MG Oral TabletPSNfc0104ef-13b9-4414-8c26-2e989d37ab0b4
351250escitalopram oxalate 20 MG Oral TabletPSN1df5c652-7bad-4b07-b33b-333071bc26704
351250escitalopram 20 MG Oral TabletSCD1df5c652-7bad-4b07-b33b-333071bc26704
351250escitalopram 20 MG Oral TabletSCDfc0104ef-13b9-4414-8c26-2e989d37ab0b4
351250escitalopram 20 MG Oral TabletSCDdabf8bc0-5de6-edce-e053-2995a90a73c94
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYfc0104ef-13b9-4414-8c26-2e989d37ab0b4
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY1df5c652-7bad-4b07-b33b-333071bc26704
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYdabf8bc0-5de6-edce-e053-2995a90a73c94
351250escitalopram oxalate 20 MG Oral TabletPSN8969aad3-0211-e67f-e053-2995a90aac5a3
351250escitalopram oxalate 20 MG Oral TabletPSN8e88bc86-d5e2-50ca-e053-2995a90a0f0e3
351250escitalopram 20 MG Oral TabletSCD8969aad3-0211-e67f-e053-2995a90aac5a3
351250escitalopram 20 MG Oral TabletSCD8e88bc86-d5e2-50ca-e053-2995a90a0f0e3
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY8969aad3-0211-e67f-e053-2995a90aac5a3
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY8e88bc86-d5e2-50ca-e053-2995a90a0f0e3
351250escitalopram oxalate 20 MG Oral TabletPSN7d791848-dd50-a47b-e053-2a91aa0ab43a1
351250escitalopram oxalate 20 MG Oral TabletPSN85b2f57e-53f3-4b93-9128-ad74cc34be4c1
351250escitalopram 20 MG Oral TabletSCD7d791848-dd50-a47b-e053-2a91aa0ab43a1
351250escitalopram 20 MG Oral TabletSCD85b2f57e-53f3-4b93-9128-ad74cc34be4c1
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY7d791848-dd50-a47b-e053-2a91aa0ab43a1
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY85b2f57e-53f3-4b93-9128-ad74cc34be4c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-170-0116729017001100 TABLET, FILM COATED in 1 BOTTLE (16729-170-01) 2013-03-210000-00-00NoNoCurrent
16729-170-101672901701030 in 1 BOTTLEHistorical
16729-170-1616729017016500 in 1 BOTTLEHistorical
16729-170-17167290170171000 TABLET, FILM COATED in 1 BOTTLE (16729-170-17) 2013-11-120000-00-00NoNoCurrent
16729-170-431672901704310 in 1 CARTONHistorical