Escitalopram Oxalate

Product NDC
16571-769
11-digit product format
165710769
Labeler code
16571
Product ID
16571-769_abf4fee5-eae0-4b5c-8b7d-7d055d36e530
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram Oxalate
Dosage form
SOLUTION
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA079062
Marketing category
ANDA
Marketing start
2012-04-03
Substance
ESCITALOPRAM OXALATE
Active strength
5 mg/5mL
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESCITALOPRAM OXALATE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui351285

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
16571-769-24Escitalopram Oxalate240 mL in 1 BOTTLESOLUTION2409

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-769-24ML - Milliliter16571-769330141f1-4551-48d2-a7d4-a75c436770e212022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-769ESCITALOPRAM OXALATE SOLUTION [RISING PHARMA HOLDINGS, INC.]9Current NDC, Legacy NDC, 1 package rows20240612_79fddc2d-2dc2-444f-8fd3-0337090ee744.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-769-2416571076924240 mL in 1 BOTTLE (16571-769-24) 240 ml2012-04-030000-00-00NoNoCurrent