FDA.reportPublic FDA data

escitalopram oxalate

Product NDC
10544-225
11-digit product format
105440225
Labeler code
10544
Product ID
10544-225_ec5c6a1e-a9e8-4b74-8175-960063bcd1a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram oxalate
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA090939
Marketing category
ANDA
Marketing start
2013-11-15
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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-225-302020-01-31C16284748780-19d75b9d0-59f8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use escitalopram tablets safely and effectively. See full prescribing information for escitalopram tablets. Escitalopram Tablets USP, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-225-30escitalopram oxalate30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-225-30EA - Each10544-225607adc34-24ed-4b28-8c9c-2517f9f3d29d12015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
10544-225ESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 1 package rows20150217_ec5c6a1e-a9e8-4b74-8175-960063bcd1a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 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 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-225-301054402253030 in 1 BOTTLEHistorical