FDA.reportPublic FDA data

escitalopram

Product NDC
13668-136
11-digit product format
136680136
Labeler code
13668
Product ID
13668-136_aa1ecae7-8a57-434f-a72b-088335b1a42c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA090939
Marketing category
ANDA
Marketing start
2012-09-11
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
escitalopram
Listing expiration
2027-12-31

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615Product name620170718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13668-136-01escitalopram100 in 1 BOTTLETABLET, FILM COATED10028
13668-136-05escitalopram500 in 1 BOTTLETABLET, FILM COATED50028
13668-136-10escitalopram1000 in 1 BOTTLETABLET, FILM COATED100028
13668-136-30escitalopram30 in 1 BOTTLETABLET, FILM COATED3028
13668-136-43escitalopram3000 in 1 BOTTLETABLET, FILM COATED300028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-136-01EA - Each13668-1363e9dd692-37c4-4759-9ac9-f53103eca81a12013-02-13
13668-136-05EA - Each13668-1367ca63863-c95b-4103-80c1-a49c917117e812013-02-13
13668-136-10EA - Each13668-1367ca374f9-9752-4f60-854e-6e6f75bab86112013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESCITALOPRAM OXALATEACTIVE INGREDIENT5U85DBW7LOESCITALOPRAM OXALATE TABLET [TORRENT PHARMACEUTICALS LIMITED]7
ESCITALOPRAMACTIVE MOIETY4O4S742ANYESCITALOPRAM OXALATE TABLET [TORRENT PHARMACEUTICALS LIMITED]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESCITALOPRAM OXALATE TABLET [TORRENT PHARMACEUTICALS LIMITED]7
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ESCITALOPRAM OXALATE TABLET [TORRENT PHARMACEUTICALS LIMITED]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ESCITALOPRAM OXALATE TABLET [TORRENT PHARMACEUTICALS LIMITED]7
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ESCITALOPRAM OXALATE TABLET [TORRENT PHARMACEUTICALS LIMITED]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESCITALOPRAM OXALATE TABLET [TORRENT PHARMACEUTICALS LIMITED]7
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQESCITALOPRAM OXALATE TABLET [TORRENT PHARMACEUTICALS LIMITED]7
POVIDONEINACTIVE INGREDIENTFZ989GH94EESCITALOPRAM OXALATE TABLET [TORRENT PHARMACEUTICALS LIMITED]7
TALCINACTIVE INGREDIENT7SEV7J4R1UESCITALOPRAM OXALATE TABLET [TORRENT PHARMACEUTICALS LIMITED]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESCITALOPRAM OXALATE TABLET [TORRENT PHARMACEUTICALS LIMITED]7
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
ESCITALOPRAM OXALATEACTIVE INGREDIENT5U85DBW7LOESCITALOPRAM OXALATE TABLET [MAJOR PHARMACEUTICALS]2
ESCITALOPRAMACTIVE MOIETY4O4S742ANYESCITALOPRAM OXALATE TABLET [MAJOR PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESCITALOPRAM OXALATE TABLET [MAJOR PHARMACEUTICALS]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ESCITALOPRAM OXALATE TABLET [MAJOR PHARMACEUTICALS]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ESCITALOPRAM OXALATE TABLET [MAJOR PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESCITALOPRAM OXALATE TABLET [MAJOR PHARMACEUTICALS]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQESCITALOPRAM OXALATE TABLET [MAJOR PHARMACEUTICALS]2
POVIDONE K12INACTIVE INGREDIENT333AG72FWJESCITALOPRAM OXALATE TABLET [MAJOR PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ESCITALOPRAM OXALATE TABLET [MAJOR PHARMACEUTICALS]2
TALCINACTIVE INGREDIENT7SEV7J4R1UESCITALOPRAM OXALATE TABLET [MAJOR PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESCITALOPRAM OXALATE TABLET [MAJOR PHARMACEUTICALS]2
ESCITALOPRAM OXALATEACTIVE INGREDIENT5U85DBW7LOESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]1
ESCITALOPRAMACTIVE MOIETY4O4S742ANYESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-136ESCITALOPRAM TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]27Current NDC, Legacy NDC, 5 package rows20250125_068bb338-23f3-4278-958b-c34b40456024.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN0de88dad-d54c-4773-a5d6-a705e012973a105
349332escitalopram 10 MG Oral TabletSCD0de88dad-d54c-4773-a5d6-a705e012973a105
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY0de88dad-d54c-4773-a5d6-a705e012973a105
349332escitalopram oxalate 10 MG Oral TabletPSN5c00c4d3-8248-4321-adec-03886c0d0f7b100
349332escitalopram 10 MG Oral TabletSCD5c00c4d3-8248-4321-adec-03886c0d0f7b100
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY5c00c4d3-8248-4321-adec-03886c0d0f7b100
349332escitalopram oxalate 10 MG Oral TabletPSNb7670e51-8f44-4f64-b110-3f2f431a403230
349332escitalopram 10 MG Oral TabletSCDb7670e51-8f44-4f64-b110-3f2f431a403230
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYb7670e51-8f44-4f64-b110-3f2f431a403230
349332escitalopram oxalate 10 MG Oral TabletPSN068bb338-23f3-4278-958b-c34b4045602428
351250escitalopram oxalate 20 MG Oral TabletPSN068bb338-23f3-4278-958b-c34b4045602428
351249escitalopram oxalate 5 MG Oral TabletPSN068bb338-23f3-4278-958b-c34b4045602428
349332escitalopram 10 MG Oral TabletSCD068bb338-23f3-4278-958b-c34b4045602428
351250escitalopram 20 MG Oral TabletSCD068bb338-23f3-4278-958b-c34b4045602428
351249escitalopram 5 MG Oral TabletSCD068bb338-23f3-4278-958b-c34b4045602428
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY068bb338-23f3-4278-958b-c34b4045602428
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY068bb338-23f3-4278-958b-c34b4045602428
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY068bb338-23f3-4278-958b-c34b4045602428
349332escitalopram oxalate 10 MG Oral TabletPSNf4a12048-181e-45ed-a382-f53096d1b68911
351250escitalopram oxalate 20 MG Oral TabletPSNf4a12048-181e-45ed-a382-f53096d1b68911
349332escitalopram 10 MG Oral TabletSCDf4a12048-181e-45ed-a382-f53096d1b68911
351250escitalopram 20 MG Oral TabletSCDf4a12048-181e-45ed-a382-f53096d1b68911
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYf4a12048-181e-45ed-a382-f53096d1b68911
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYf4a12048-181e-45ed-a382-f53096d1b68911
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
349332escitalopram oxalate 10 MG Oral TabletPSN643dbe13-a06c-0d18-e053-2991aa0aa1bc5
349332escitalopram 10 MG Oral TabletSCD643dbe13-a06c-0d18-e053-2991aa0aa1bc5
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY643dbe13-a06c-0d18-e053-2991aa0aa1bc5
349332escitalopram oxalate 10 MG Oral TabletPSN7d924d16-8a10-411d-be57-97c450f56de74
349332escitalopram oxalate 10 MG Oral TabletPSN4f434cbc-318b-6554-e054-00144ff88e884
349332escitalopram 10 MG Oral TabletSCD7d924d16-8a10-411d-be57-97c450f56de74
349332escitalopram 10 MG Oral TabletSCD4f434cbc-318b-6554-e054-00144ff88e884
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY4f434cbc-318b-6554-e054-00144ff88e884
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY7d924d16-8a10-411d-be57-97c450f56de74
349332escitalopram oxalate 10 MG Oral TabletPSN76a2dcaf-7b75-2f53-e053-2991aa0addf53
349332escitalopram 10 MG Oral TabletSCD76a2dcaf-7b75-2f53-e053-2991aa0addf53
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY76a2dcaf-7b75-2f53-e053-2991aa0addf53
349332escitalopram oxalate 10 MG Oral TabletPSNfaa48e9c-a34c-c745-e053-6294a90a9b212
349332escitalopram 10 MG Oral TabletSCDfaa48e9c-a34c-c745-e053-6294a90a9b212
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYfaa48e9c-a34c-c745-e053-6294a90a9b212
349332escitalopram oxalate 10 MG Oral TabletPSNec5c6a1e-a9e8-4b74-8175-960063bcd1a21
349332escitalopram oxalate 10 MG Oral TabletPSN9af36828-fb7d-d5f3-e053-2a95a90ad4731
349332escitalopram oxalate 10 MG Oral TabletPSN8201a719-7837-45fb-b991-4fcdbf006d241
351250escitalopram oxalate 20 MG Oral TabletPSNec5c6a1e-a9e8-4b74-8175-960063bcd1a21
351249escitalopram oxalate 5 MG Oral TabletPSNec5c6a1e-a9e8-4b74-8175-960063bcd1a21
349332escitalopram 10 MG Oral TabletSCDec5c6a1e-a9e8-4b74-8175-960063bcd1a21
349332escitalopram 10 MG Oral TabletSCD9af36828-fb7d-d5f3-e053-2a95a90ad4731
349332escitalopram 10 MG Oral TabletSCD8201a719-7837-45fb-b991-4fcdbf006d241
351250escitalopram 20 MG Oral TabletSCDec5c6a1e-a9e8-4b74-8175-960063bcd1a21
351249escitalopram 5 MG Oral TabletSCDec5c6a1e-a9e8-4b74-8175-960063bcd1a21
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY8201a719-7837-45fb-b991-4fcdbf006d241
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYec5c6a1e-a9e8-4b74-8175-960063bcd1a21
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY9af36828-fb7d-d5f3-e053-2a95a90ad4731
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYec5c6a1e-a9e8-4b74-8175-960063bcd1a21
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSYec5c6a1e-a9e8-4b74-8175-960063bcd1a21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-136-0113668013601100 TABLET, FILM COATED in 1 BOTTLE (13668-136-01) 2012-09-110000-00-00NoNoCurrent
13668-136-0513668013605500 TABLET, FILM COATED in 1 BOTTLE (13668-136-05) 2012-09-110000-00-00NoNoCurrent
13668-136-10136680136101000 TABLET, FILM COATED in 1 BOTTLE (13668-136-10) 2012-09-110000-00-00NoNoCurrent
13668-136-301366801363030 TABLET, FILM COATED in 1 BOTTLE (13668-136-30) 2012-09-110000-00-00NoNoCurrent
13668-136-43136680136433000 TABLET, FILM COATED in 1 BOTTLE (13668-136-43) 2012-09-110000-00-00NoNoCurrent
13668-136-7413668013674100 TABLET in 1 CARTON (13668-136-74) 100 tablet2012-09-110000-00-00NoNoCurrent