escitalopram oxalate

Product NDC
82009-037
11-digit product format
820090037
Labeler code
82009
Product ID
82009-037_8535cead-aff5-4a22-b788-1d5926e02097
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram oxalate
Dosage form
TABLET
Route
ORAL
Labeler
Quallent Pharmaceuticals Health LLC
Application
ANDA090939
Marketing category
ANDA
Marketing start
2023-03-01
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 oxalate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESCITALOPRAM OXALATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui349332, 351249, 351250

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
82009-037-10escitalopram oxalate1000 in 1 BOTTLETABLET10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82009-037-10EA - Each82009-0377cb0724d-d497-48b4-aa65-f225c00775f112023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82009-037ESCITALOPRAM OXALATE TABLET [QUALLENT PHARMACEUTICALS HEALTH LLC]9Current NDC, 1 package rows20241027_d8e22060-4d06-42bf-a881-caaf65ecc3e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSNd8e22060-4d06-42bf-a881-caaf65ecc3e39
351250escitalopram oxalate 20 MG Oral TabletPSNd8e22060-4d06-42bf-a881-caaf65ecc3e39
351249escitalopram oxalate 5 MG Oral TabletPSNd8e22060-4d06-42bf-a881-caaf65ecc3e39
349332escitalopram 10 MG Oral TabletSCDd8e22060-4d06-42bf-a881-caaf65ecc3e39
351250escitalopram 20 MG Oral TabletSCDd8e22060-4d06-42bf-a881-caaf65ecc3e39
351249escitalopram 5 MG Oral TabletSCDd8e22060-4d06-42bf-a881-caaf65ecc3e39
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYd8e22060-4d06-42bf-a881-caaf65ecc3e39
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYd8e22060-4d06-42bf-a881-caaf65ecc3e39
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSYd8e22060-4d06-42bf-a881-caaf65ecc3e39

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82009-037-10820090037101000 TABLET in 1 BOTTLE (82009-037-10) 1000 tablet2023-03-01NoNoCurrent