FDA.reportPublic FDA data

Escitalopram

Product NDC
68180-135
11-digit product format
681800135
Labeler code
68180
Product ID
68180-135_bd9ecc53-f6db-4750-8d73-6081cf03afa0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitslopram
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA078169
Marketing category
ANDA
Marketing start
2012-09-10
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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
68180-135-01Escitalopram100 in 1 BOTTLETABLET10021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-135-01EA - Each68180-1352e31a350-6070-4e58-8925-016d47f5342a12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESCITALOPRAM OXALATEACTIVE INGREDIENT5U85DBW7LOESCITALOPRAM (ESCITSLOPRAM) TABLET [LUPIN PHARMACEUTICALS, INC.]11
ESCITALOPRAMACTIVE MOIETY4O4S742ANYESCITALOPRAM (ESCITSLOPRAM) TABLET [LUPIN PHARMACEUTICALS, INC.]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESCITALOPRAM (ESCITSLOPRAM) TABLET [LUPIN PHARMACEUTICALS, INC.]11
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ESCITALOPRAM (ESCITSLOPRAM) TABLET [LUPIN PHARMACEUTICALS, INC.]11
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4ESCITALOPRAM (ESCITSLOPRAM) TABLET [LUPIN PHARMACEUTICALS, INC.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESCITALOPRAM (ESCITSLOPRAM) TABLET [LUPIN PHARMACEUTICALS, INC.]11
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQESCITALOPRAM (ESCITSLOPRAM) TABLET [LUPIN PHARMACEUTICALS, INC.]11
TALCINACTIVE INGREDIENT7SEV7J4R1UESCITALOPRAM (ESCITSLOPRAM) TABLET [LUPIN PHARMACEUTICALS, INC.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESCITALOPRAM (ESCITSLOPRAM) TABLET [LUPIN PHARMACEUTICALS, INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-135ESCITALOPRAM (ESCITSLOPRAM) TABLET [LUPIN PHARMACEUTICALS, INC.]21Legacy NDC, 1 package rows20231219_41f7392a-1f5c-4542-9c5c-f9e109851381.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN41f7392a-1f5c-4542-9c5c-f9e10985138121
351250escitalopram oxalate 20 MG Oral TabletPSN41f7392a-1f5c-4542-9c5c-f9e10985138121
351249escitalopram oxalate 5 MG Oral TabletPSN41f7392a-1f5c-4542-9c5c-f9e10985138121
349332escitalopram 10 MG Oral TabletSCD41f7392a-1f5c-4542-9c5c-f9e10985138121
351250escitalopram 20 MG Oral TabletSCD41f7392a-1f5c-4542-9c5c-f9e10985138121
351249escitalopram 5 MG Oral TabletSCD41f7392a-1f5c-4542-9c5c-f9e10985138121
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY41f7392a-1f5c-4542-9c5c-f9e10985138121
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY41f7392a-1f5c-4542-9c5c-f9e10985138121
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY41f7392a-1f5c-4542-9c5c-f9e10985138121
349332escitalopram oxalate 10 MG Oral TabletPSN25d450c1-932f-4f5e-b5f7-d3824d3c4efd1
349332escitalopram oxalate 10 MG Oral TabletPSNb61790d5-8913-413e-ab0a-f6da0ffdd5341
349332escitalopram 10 MG Oral TabletSCD25d450c1-932f-4f5e-b5f7-d3824d3c4efd1
349332escitalopram 10 MG Oral TabletSCDb61790d5-8913-413e-ab0a-f6da0ffdd5341
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY25d450c1-932f-4f5e-b5f7-d3824d3c4efd1
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYb61790d5-8913-413e-ab0a-f6da0ffdd5341

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-135-0168180013501100 TABLET in 1 BOTTLE (68180-135-01) 100 tablet2012-09-100000-00-00NoNoCurrent