FDA.reportPublic FDA data

Escitalopram Oxalate

Product NDC
0378-3856
11-digit product format
003783856
Labeler code
0378
Product ID
0378-3856_6404ddfe-f72d-4237-aea2-542cd677467e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA021323
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-02-29
Marketing end
2019-11-30
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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615Product name620170718

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-3856-10EA - Each0378-3856e216b664-0c59-44e3-b10e-e63a5a0f83e812012-07-24
0378-3856-77EA - Each0378-385631dbb592-6a23-4428-aa39-516d35929dd712012-07-24
0378-3856-93EA - Each0378-3856b0cb9346-8a86-4881-8f90-482906c75e6412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESCITALOPRAM OXALATEACTIVE INGREDIENT5U85DBW7LOESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
ESCITALOPRAMACTIVE MOIETY4O4S742ANYESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN2b982098-bbdc-472f-e054-00144ff8d46c2
351250escitalopram oxalate 20 MG Oral TabletPSN2b982098-bbdc-472f-e054-00144ff8d46c2
349332escitalopram 10 MG Oral TabletSCD2b982098-bbdc-472f-e054-00144ff8d46c2
351250escitalopram 20 MG Oral TabletSCD2b982098-bbdc-472f-e054-00144ff8d46c2
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY2b982098-bbdc-472f-e054-00144ff8d46c2
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY2b982098-bbdc-472f-e054-00144ff8d46c2
349332escitalopram oxalate 10 MG Oral TabletPSN44849ca6-9828-4168-8e3a-7ffc2045fbc61
351250escitalopram oxalate 20 MG Oral TabletPSN44849ca6-9828-4168-8e3a-7ffc2045fbc61
349332escitalopram 10 MG Oral TabletSCD44849ca6-9828-4168-8e3a-7ffc2045fbc61
351250escitalopram 20 MG Oral TabletSCD44849ca6-9828-4168-8e3a-7ffc2045fbc61
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY44849ca6-9828-4168-8e3a-7ffc2045fbc61
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY44849ca6-9828-4168-8e3a-7ffc2045fbc61