FDA.reportPublic FDA data

Escitalopram

Product NDC
67296-1421
11-digit product format
672961421
Labeler code
67296
Product ID
67296-1421_2c6228e2-dbab-01e7-e063-6394a90acbbc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA078032
Marketing category
ANDA
Marketing start
2012-03-15
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESCITALOPRAM OXALATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui351250

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
67296-1421-72023-01-30C16284748780-1f386c649-f01b-0266-e053-dadaa90a7c1aESCITALOPRAM 20mg TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1421-7Escitalopram7 in 1 BOTTLETABLET, FILM COATED73
67296-1421-3Escitalopram30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1421ESCITALOPRAM TABLET, FILM COATED [REDPHARM DRUG, INC.]3Current NDC, Legacy NDC, 1 package rows20210216_bb66252e-3a0f-7240-e053-2a95a90acfd9.zip
67296-1421ESCITALOPRAM TABLET, FILM COATED [REDPHARM DRUG, INC.]2Current NDC, Legacy NDC, 1 package rows20250124_fc61822a-4058-343c-e053-6294a90af72c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351250escitalopram oxalate 20 MG Oral TabletPSNbb66252e-3a0f-7240-e053-2a95a90acfd93
351250escitalopram 20 MG Oral TabletSCDbb66252e-3a0f-7240-e053-2a95a90acfd93
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYbb66252e-3a0f-7240-e053-2a95a90acfd93
351250escitalopram oxalate 20 MG Oral TabletPSNfc61822a-4058-343c-e053-6294a90af72c2
351250escitalopram 20 MG Oral TabletSCDfc61822a-4058-343c-e053-6294a90af72c2
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYfc61822a-4058-343c-e053-6294a90af72c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1421-36729614210330 TABLET, FILM COATED in 1 BOTTLE (67296-1421-3) 2021-02-01NoNoHistorical
67296-1421-7672961421077 TABLET, FILM COATED in 1 BOTTLE (67296-1421-7) 2021-02-010000-00-00NoNoCurrent