FDA.reportPublic FDA data

escitalopram

Product NDC
0904-6427
11-digit product format
009046427
Labeler code
0904
Product ID
0904-6427_6dd4eb62-4211-41c7-8592-69c0b045b53f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA090939
Marketing category
ANDA
Marketing start
2014-10-15
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, 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
0904-6427-61escitalopram1 in 1 BLISTER PACKTABLET, FILM COATED111
0904-6427-61escitalopram100 in 1 CARTONTABLET, FILM COATED10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6427-61EA - Each0904-6427caeae26c-18c7-4615-bf04-8fa617bc60e312014-11-05

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6427ESCITALOPRAM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]10Current NDC, Legacy NDC, 2 package rows20250216_f4a12048-181e-45ed-a382-f53096d1b689.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSNcb3f9af4-5bb4-48a8-b972-ff92cff1ea0119
351250escitalopram oxalate 20 MG Oral TabletPSNcb3f9af4-5bb4-48a8-b972-ff92cff1ea0119
349332escitalopram 10 MG Oral TabletSCDcb3f9af4-5bb4-48a8-b972-ff92cff1ea0119
351250escitalopram 20 MG Oral TabletSCDcb3f9af4-5bb4-48a8-b972-ff92cff1ea0119
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYcb3f9af4-5bb4-48a8-b972-ff92cff1ea0119
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYcb3f9af4-5bb4-48a8-b972-ff92cff1ea0119
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6427-6100904642761100 BLISTER PACK in 1 CARTON (0904-6427-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2014-10-150000-00-00NoNoCurrent