escitalopram oxalate

Product NDC
82982-065
11-digit product format
829820065
Labeler code
82982
Product ID
82982-065_198ba216-39a7-3d98-e063-6394a90a9f0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram oxalate
Dosage form
TABLET
Route
ORAL
Labeler
Pharmasource Meds, LLC
Application
ANDA090939
Marketing category
ANDA
Marketing start
2023-05-01
Marketing end
2026-07-31
Substance
ESCITALOPRAM OXALATE
Active strength
10 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
escitalopram oxalate

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
82982-065-60escitalopram oxalate60 in 1 BOTTLETABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82982-065ESCITALOPRAM OXALATE TABLET [PHARMASOURCE MEDS, LLC]2Current NDC, 1 package rows20240601_faa48e9c-a34c-c745-e053-6294a90a9b21.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSNfaa48e9c-a34c-c745-e053-6294a90a9b212
349332escitalopram 10 MG Oral TabletSCDfaa48e9c-a34c-c745-e053-6294a90a9b212
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYfaa48e9c-a34c-c745-e053-6294a90a9b212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82982-065-608298200656060 TABLET in 1 BOTTLE (82982-065-60) 60 tablet2023-05-012026-07-31NoNoHistorical