FDA.reportPublic FDA data

escitalopram

Product NDC
13668-137
11-digit product format
136680137
Labeler code
13668
Product ID
13668-137_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
20 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 OXALATE20 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
13668-137-01escitalopram100 in 1 BOTTLETABLET, FILM COATED10028
13668-137-05escitalopram500 in 1 BOTTLETABLET, FILM COATED50028
13668-137-10escitalopram1000 in 1 BOTTLETABLET, FILM COATED100028
13668-137-20escitalopram2000 in 1 BOTTLETABLET, FILM COATED200028
13668-137-30escitalopram30 in 1 BOTTLETABLET, FILM COATED3028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-137-01EA - Each13668-137a2c07a08-f60c-400a-9376-d0b5d01c223a12013-02-13
13668-137-05EA - Each13668-137b1c723e6-a591-4c64-8347-fb47bbea2e5812013-02-13
13668-137-10EA - Each13668-137877d21dd-0fba-4e8b-8dfd-050c2b5e864712013-11-04

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]6
ESCITALOPRAMACTIVE MOIETY4O4S742ANYESCITALOPRAM OXALATE TABLET [DIRECT RX]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESCITALOPRAM OXALATE TABLET [DIRECT RX]6
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ESCITALOPRAM OXALATE TABLET [DIRECT RX]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ESCITALOPRAM OXALATE TABLET [DIRECT RX]6
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ESCITALOPRAM OXALATE TABLET [DIRECT RX]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESCITALOPRAM OXALATE TABLET [DIRECT RX]6
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQESCITALOPRAM OXALATE TABLET [DIRECT RX]6
POVIDONEINACTIVE INGREDIENTFZ989GH94EESCITALOPRAM OXALATE TABLET [DIRECT RX]6
TALCINACTIVE INGREDIENT7SEV7J4R1UESCITALOPRAM OXALATE TABLET [DIRECT RX]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESCITALOPRAM OXALATE TABLET [DIRECT RX]6
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
ESCITALOPRAM OXALATEACTIVE INGREDIENT5U85DBW7LOESCITALOPRAM OXALATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
ESCITALOPRAMACTIVE MOIETY4O4S742ANYESCITALOPRAM OXALATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
ESCITALOPRAMACTIVE MOIETY4O4S742ANYESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESCITALOPRAM OXALATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ESCITALOPRAM OXALATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ESCITALOPRAM OXALATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESCITALOPRAM OXALATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQESCITALOPRAM OXALATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EESCITALOPRAM OXALATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ESCITALOPRAM OXALATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UESCITALOPRAM OXALATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESCITALOPRAM OXALATE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-137ESCITALOPRAM 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
351250escitalopram oxalate 20 MG Oral TabletPSN86cfcd96-6397-42ef-8a79-f62706f0aca6106
351250escitalopram 20 MG Oral TabletSCD86cfcd96-6397-42ef-8a79-f62706f0aca6106
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY86cfcd96-6397-42ef-8a79-f62706f0aca6106
351250escitalopram oxalate 20 MG Oral TabletPSNcb30d1c5-2280-465f-84f4-4367ad5f1a31105
351250escitalopram 20 MG Oral TabletSCDcb30d1c5-2280-465f-84f4-4367ad5f1a31105
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYcb30d1c5-2280-465f-84f4-4367ad5f1a31105
351250escitalopram oxalate 20 MG Oral TabletPSN1d2f83c1-8ffe-48f3-a084-150289001743100
351250escitalopram 20 MG Oral TabletSCD1d2f83c1-8ffe-48f3-a084-150289001743100
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY1d2f83c1-8ffe-48f3-a084-150289001743100
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
351250escitalopram oxalate 20 MG Oral TabletPSNdfe724f8-c6f3-4f0f-8466-4abce161f15a6
351250escitalopram 20 MG Oral TabletSCDdfe724f8-c6f3-4f0f-8466-4abce161f15a6
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYdfe724f8-c6f3-4f0f-8466-4abce161f15a6
351250escitalopram oxalate 20 MG Oral TabletPSN6ccfae22-b0bc-3e07-e053-2991aa0a40513
351250escitalopram oxalate 20 MG Oral TabletPSNf6cacd68-0f55-deb9-e053-6294a90aa2663
351250escitalopram 20 MG Oral TabletSCD6ccfae22-b0bc-3e07-e053-2991aa0a40513
351250escitalopram 20 MG Oral TabletSCDf6cacd68-0f55-deb9-e053-6294a90aa2663
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY6ccfae22-b0bc-3e07-e053-2991aa0a40513
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYf6cacd68-0f55-deb9-e053-6294a90aa2663
349332escitalopram oxalate 10 MG Oral TabletPSNec5c6a1e-a9e8-4b74-8175-960063bcd1a21
351250escitalopram oxalate 20 MG Oral TabletPSNdccbf03a-bab2-4307-a89f-70d2c3b762d21
351250escitalopram oxalate 20 MG Oral TabletPSN5a05b94a-6dd9-572e-e053-2a91aa0a660f1
351250escitalopram oxalate 20 MG Oral TabletPSN5163a9cf-5ab7-592c-e054-00144ff88e881
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
351250escitalopram 20 MG Oral TabletSCDdccbf03a-bab2-4307-a89f-70d2c3b762d21
351250escitalopram 20 MG Oral TabletSCD5163a9cf-5ab7-592c-e054-00144ff88e881
351250escitalopram 20 MG Oral TabletSCD5a05b94a-6dd9-572e-e053-2a91aa0a660f1
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 TabletSYec5c6a1e-a9e8-4b74-8175-960063bcd1a21
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYec5c6a1e-a9e8-4b74-8175-960063bcd1a21
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYdccbf03a-bab2-4307-a89f-70d2c3b762d21
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY5163a9cf-5ab7-592c-e054-00144ff88e881
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY5a05b94a-6dd9-572e-e053-2a91aa0a660f1
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
13668-137-0113668013701100 TABLET, FILM COATED in 1 BOTTLE (13668-137-01) 2012-09-110000-00-00NoNoCurrent
13668-137-0513668013705500 TABLET, FILM COATED in 1 BOTTLE (13668-137-05) 2012-09-110000-00-00NoNoCurrent
13668-137-10136680137101000 TABLET, FILM COATED in 1 BOTTLE (13668-137-10) 2012-09-110000-00-00NoNoCurrent
13668-137-20136680137202000 TABLET, FILM COATED in 1 BOTTLE (13668-137-20) 2012-09-110000-00-00NoNoCurrent
13668-137-301366801373030 TABLET, FILM COATED in 1 BOTTLE (13668-137-30) 2012-09-110000-00-00NoNoCurrent
13668-137-7413668013774100 TABLET in 1 CARTON (13668-137-74) 100 tablet2012-09-110000-00-00NoNoCurrent