FDA.reportPublic FDA data

Escitalopram

Product NDC
50090-5312
11-digit product format
500905312
Labeler code
50090
Product ID
50090-5312_5d70869d-59cb-4cbe-80a1-0b4106c4eab0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078032
Marketing category
ANDA
Marketing start
2016-02-01
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESCITALOPRAM OXALATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui351249

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
50090-5312-02023-02-07C16284748780-1f386c649-e3eb-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
50090-5312-02023-01-30C16284748780-1f386c649-e3eb-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5312-0Escitalopram90 in 1 BOTTLETABLET, FILM COATED905
50090-5312-1Escitalopram30 in 1 BOTTLETABLET, FILM COATED305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5312-0EA - Each50090-53127f2b4f7f-8e08-4b69-ab74-d12c812778ba12023-08-08
50090-5312-1EA - Each50090-531284de769b-b8d0-4cba-9ba9-f2b12881863912023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5312ESCITALOPRAM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20230725_9b0b3c54-5bbc-4db9-9c69-00dac1347f24.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351249escitalopram oxalate 5 MG Oral TabletPSN9b0b3c54-5bbc-4db9-9c69-00dac1347f245
351249escitalopram 5 MG Oral TabletSCD9b0b3c54-5bbc-4db9-9c69-00dac1347f245
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY9b0b3c54-5bbc-4db9-9c69-00dac1347f245

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5312-05009053120090 TABLET, FILM COATED in 1 BOTTLE (50090-5312-0) 2020-10-290000-00-00NoNoCurrent
50090-5312-15009053120130 TABLET, FILM COATED in 1 BOTTLE (50090-5312-1) 2023-07-13NoNoHistorical