Escitalopram

Product NDC
42708-163
11-digit product format
427080163
Labeler code
42708
Product ID
42708-163_4586cb37-a5df-2caf-e063-6294a90a48c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
QPharma, Inc.
Application
ANDA078032
Marketing category
ANDA
Marketing start
2016-02-01
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42708-163-30Escitalopram30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42708-163ESCITALOPRAM TABLET, FILM COATED [QPHARMA, INC.]3Current NDC, 1 package rows20250522_f682f991-1807-176a-e053-2995a90a3dfa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351250escitalopram oxalate 20 MG Oral TabletPSNf682f991-1807-176a-e053-2995a90a3dfa4
351250escitalopram 20 MG Oral TabletSCDf682f991-1807-176a-e053-2995a90a3dfa4
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYf682f991-1807-176a-e053-2995a90a3dfa4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42708-163-304270801633030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42708-163-30) 2023-03-13YesNoHistorical