FDA.reportPublic FDA data

Escitalopram Oral Solution

Product NDC
62135-729
11-digit product format
621350729
Labeler code
62135
Product ID
62135-729_2f987c95-695b-d900-e063-6294a90a0cf8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram Oral
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA090477
Marketing category
ANDA
Marketing start
2023-06-12
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 Oral Solution
Listing expiration
2026-12-31

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615Product name620170718
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-729-10Escitalopram Oral Solution10 mL in 1 CUPSOLUTION103
62135-729-24Escitalopram Oral Solution10 in 1 TRAYSOLUTION103
62135-729-24Escitalopram Oral Solution2 in 1 BOXSOLUTION23
62135-729-37Escitalopram Oral Solution240 mL in 1 BOTTLESOLUTION2403

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-729-10ML - Milliliter62135-7295a965ac6-3d98-44b7-a287-2b07b58b0de312025-05-14
62135-729-24ML - Milliliter62135-729dde72336-ad69-40c3-986c-0e2bc5a66f4512025-05-14
62135-729-37ML - Milliliter62135-7295f76c9fe-16dd-4a7f-97dd-0dfea10cd32d12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-729ESCITALOPRAM ORAL SOLUTION (ESCITALOPRAM ORAL) SOLUTION [CHARTWELL RX, LLC]3Current NDC, 4 package rows20250308_0458445b-e431-4c82-86b8-90373813c10a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351285escitalopram 5 MG in 5 mL Oral SolutionPSN0458445b-e431-4c82-86b8-90373813c10a3
351285escitalopram 1 MG/ML Oral SolutionSCD0458445b-e431-4c82-86b8-90373813c10a3
351285escitalopram (as escitalopram oxalate) 10 MG per 10 ML Oral SolutionSY0458445b-e431-4c82-86b8-90373813c10a3
351285escitalopram (as escitalopram oxalate) 5 MG per 5 ML Oral SolutionSY0458445b-e431-4c82-86b8-90373813c10a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-729-106213507291010 mL in 1 CUP10 mlHistorical
62135-729-24621350729242 TRAY in 1 BOX (62135-729-24) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-729-10) 2 tray2025-02-26NoNoCurrent
62135-729-3762135072937240 mL in 1 BOTTLE (62135-729-37) 240 ml2023-08-11NoNoCurrent