FDA.reportPublic FDA data

escitalopram oxalate

Product NDC
43063-761
11-digit product format
430630761
Labeler code
43063
Product ID
43063-761_419e34ea-17b4-ec32-e063-6394a90a603d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram oxalate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA090939
Marketing category
ANDA
Marketing start
2012-09-11
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615Product name620170718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-761-01escitalopram oxalate100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10030
43063-761-30escitalopram oxalate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3030
43063-761-90escitalopram oxalate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-761-01EA - Each43063-76101bf4b12-7368-4d3f-841c-ec369d07e68212017-06-15
43063-761-30EA - Each43063-76180968283-fbe8-4838-93b3-38b5483b69b612017-07-07
43063-761-90EA - Each43063-76128b8afea-6a5f-4069-8c64-66c08667c9ec12017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-761ESCITALOPRAM OXALATE TABLET [PD-RX PHARMACEUTICALS, INC.]29Current NDC, Legacy NDC, 3 package rows20241109_b7670e51-8f44-4f64-b110-3f2f431a4032.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSNb7670e51-8f44-4f64-b110-3f2f431a403230
349332escitalopram 10 MG Oral TabletSCDb7670e51-8f44-4f64-b110-3f2f431a403230
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYb7670e51-8f44-4f64-b110-3f2f431a403230

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-761-0143063076101100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-761-01) 2017-05-250000-00-00NoNoCurrent
43063-761-304306307613030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-761-30) 2017-05-250000-00-00NoNoCurrent
43063-761-904306307619090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-761-90) 2017-05-030000-00-00NoNoCurrent