FDA.reportPublic FDA data

Escitalopram

Product NDC
70518-4567
11-digit product format
705184567
Labeler code
70518
Product ID
70518-4567_4a13e11b-5f03-a0c1-e063-6294a90aa2f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078032
Marketing category
ANDA
Marketing start
2026-02-04
Substance
ESCITALOPRAM OXALATE
Active strength
10 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Escitalopram
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESCITALOPRAM OXALATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui349332

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615Product name620170718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4567-0Escitalopram30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSN0ef807d2-5d66-40c2-be3e-ff6176a352951
349332escitalopram 10 MG Oral TabletSCD0ef807d2-5d66-40c2-be3e-ff6176a352951
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY0ef807d2-5d66-40c2-be3e-ff6176a352951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4567-07051845670030 TABLET, FILM COATED in 1 BLISTER PACK (70518-4567-0) 2026-02-04NoNoCurrent