FDA.reportPublic FDA data

Escitalopram

Product NDC
43063-661
11-digit product format
430630661
Labeler code
43063
Product ID
43063-661_51183286-0aa4-1fe2-e063-6394a90ae06e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA202389
Marketing category
ANDA
Marketing start
2013-03-21
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
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 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
43063-661-30Escitalopram30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3025
43063-661-90Escitalopram90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-661-30EA - Each43063-66189ecf3aa-eabd-4fea-85a0-a42c74f7832612016-04-04
43063-661-90EA - Each43063-6611ba0d225-9ba5-47a4-ab41-49057ddd5caf12016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-661ESCITALOPRAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]24Current NDC, Legacy NDC, 2 package rows20250110_2d125ea4-5430-5b4e-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351250escitalopram oxalate 20 MG Oral TabletPSN2d125ea4-5430-5b4e-e054-00144ff88e8825
351250escitalopram 20 MG Oral TabletSCD2d125ea4-5430-5b4e-e054-00144ff88e8825
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY2d125ea4-5430-5b4e-e054-00144ff88e8825

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-661-304306306613030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-661-30) 2016-03-030000-00-00NoNoCurrent
43063-661-904306306619090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-661-90) 2016-03-030000-00-00NoNoCurrent