FDA.reportPublic FDA data

escitalopram

Product NDC
13668-135
11-digit product format
136680135
Labeler code
13668
Product ID
13668-135_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
5 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 OXALATE5 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
13668-135-01escitalopram100 in 1 BOTTLETABLET, FILM COATED10028
13668-135-05escitalopram500 in 1 BOTTLETABLET, FILM COATED50028
13668-135-10escitalopram1000 in 1 BOTTLETABLET, FILM COATED100028
13668-135-30escitalopram30 in 1 BOTTLETABLET, FILM COATED3028
13668-135-40escitalopram4000 in 1 BOTTLETABLET, FILM COATED400028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-135-01EA - Each13668-135f24046e3-d2ee-4d24-8948-72aa927fc4fd12013-02-13
13668-135-05EA - Each13668-13542888c1a-fb4a-4861-9588-e356fcf0536212013-02-13
13668-135-10EA - Each13668-1350aa4b532-59e9-4a2c-aa7d-289a1a18333d12013-11-04

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 [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
13668-135ESCITALOPRAM 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
351249escitalopram oxalate 5 MG Oral TabletPSNa0ff752d-cb30-4131-a7d6-cd66d8a47b1a105
351249escitalopram 5 MG Oral TabletSCDa0ff752d-cb30-4131-a7d6-cd66d8a47b1a105
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSYa0ff752d-cb30-4131-a7d6-cd66d8a47b1a105
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
351249escitalopram oxalate 5 MG Oral TabletPSNe773030f-d07d-4bb8-9dc9-6f649688346d3
351249escitalopram 5 MG Oral TabletSCDe773030f-d07d-4bb8-9dc9-6f649688346d3
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSYe773030f-d07d-4bb8-9dc9-6f649688346d3
351249escitalopram oxalate 5 MG Oral TabletPSN5cc83a3e-46bc-3b58-e053-2a91aa0a33822
351249escitalopram 5 MG Oral TabletSCD5cc83a3e-46bc-3b58-e053-2a91aa0a33822
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY5cc83a3e-46bc-3b58-e053-2a91aa0a33822
349332escitalopram oxalate 10 MG Oral TabletPSNec5c6a1e-a9e8-4b74-8175-960063bcd1a21
351250escitalopram oxalate 20 MG Oral TabletPSNec5c6a1e-a9e8-4b74-8175-960063bcd1a21
351249escitalopram oxalate 5 MG Oral TabletPSN54c98db4-3430-4423-afce-1262810336ae1
351249escitalopram oxalate 5 MG Oral TabletPSNec5c6a1e-a9e8-4b74-8175-960063bcd1a21
349332escitalopram 10 MG Oral TabletSCDec5c6a1e-a9e8-4b74-8175-960063bcd1a21
351250escitalopram 20 MG Oral TabletSCDec5c6a1e-a9e8-4b74-8175-960063bcd1a21
351249escitalopram 5 MG Oral TabletSCD54c98db4-3430-4423-afce-1262810336ae1
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
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSYec5c6a1e-a9e8-4b74-8175-960063bcd1a21
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY54c98db4-3430-4423-afce-1262810336ae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-135-0113668013501100 TABLET, FILM COATED in 1 BOTTLE (13668-135-01) 2012-09-110000-00-00NoNoCurrent
13668-135-0513668013505500 TABLET, FILM COATED in 1 BOTTLE (13668-135-05) 2012-09-110000-00-00NoNoCurrent
13668-135-10136680135101000 TABLET, FILM COATED in 1 BOTTLE (13668-135-10) 2012-09-110000-00-00NoNoCurrent
13668-135-301366801353030 TABLET, FILM COATED in 1 BOTTLE (13668-135-30) 2012-09-110000-00-00NoNoCurrent
13668-135-40136680135404000 TABLET, FILM COATED in 1 BOTTLE (13668-135-40) 2012-09-110000-00-00NoNoCurrent
13668-135-7413668013574100 TABLET in 1 CARTON (13668-135-74) 100 tablet2012-09-110000-00-00NoNoCurrent