Escitalopram Oxalate

Product NDC
33342-036
11-digit product format
333420036
Labeler code
33342
Product ID
33342-036_53210109-53db-4d08-8ea4-be60e5597caf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram Oxalate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA202210
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Escitalopram Oxalate
Listing expiration
2026-12-31

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615Product name620170718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-036-11Escitalopram Oxalate100 in 1 BOTTLETABLET, FILM COATED10021
33342-036-12Escitalopram Oxalate100 in 1 CARTONTABLET, FILM COATED10021
33342-036-15Escitalopram Oxalate500 in 1 BOTTLETABLET, FILM COATED50021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-036-11EA - Each33342-0362ae632b1-ff59-4ece-9af3-9e2f5140fb3612014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESCITALOPRAM OXALATEACTIVE INGREDIENT5U85DBW7LOESCITALOPRAM OXALATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
ESCITALOPRAMACTIVE MOIETY4O4S742ANYESCITALOPRAM OXALATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311ESCITALOPRAM OXALATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ESCITALOPRAM OXALATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ESCITALOPRAM OXALATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302ESCITALOPRAM OXALATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XESCITALOPRAM OXALATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESCITALOPRAM OXALATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQESCITALOPRAM OXALATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92ESCITALOPRAM OXALATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ESCITALOPRAM OXALATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
TALCINACTIVE INGREDIENT7SEV7J4R1UESCITALOPRAM OXALATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESCITALOPRAM OXALATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-036ESCITALOPRAM OXALATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]21Current NDC, Legacy NDC, 3 package rows20240525_24b43cb4-1a26-44a2-b1d8-a40239eb5c7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN24b43cb4-1a26-44a2-b1d8-a40239eb5c7c21
351250escitalopram oxalate 20 MG Oral TabletPSN24b43cb4-1a26-44a2-b1d8-a40239eb5c7c21
351249escitalopram oxalate 5 MG Oral TabletPSN24b43cb4-1a26-44a2-b1d8-a40239eb5c7c21
349332escitalopram 10 MG Oral TabletSCD24b43cb4-1a26-44a2-b1d8-a40239eb5c7c21
351250escitalopram 20 MG Oral TabletSCD24b43cb4-1a26-44a2-b1d8-a40239eb5c7c21
351249escitalopram 5 MG Oral TabletSCD24b43cb4-1a26-44a2-b1d8-a40239eb5c7c21
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY24b43cb4-1a26-44a2-b1d8-a40239eb5c7c21
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY24b43cb4-1a26-44a2-b1d8-a40239eb5c7c21
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY24b43cb4-1a26-44a2-b1d8-a40239eb5c7c21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
33342-036-1133342003611100 TABLET, FILM COATED in 1 BOTTLE (33342-036-11) 2012-09-11NoNoHistorical
33342-036-1233342003612100 TABLET, FILM COATED in 1 CARTON (33342-036-12) 2012-09-11NoNoHistorical
33342-036-1533342003615500 TABLET, FILM COATED in 1 BOTTLE (33342-036-15) 2015-09-09NoNoHistorical