Escitalopram Oral Solution

Product NDC
68999-729
11-digit product format
689990729
Labeler code
68999
Product ID
68999-729_499eac58-9e20-d82d-e063-6294a90a6b46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram Oral
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell Governmental & Specialty 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Escitalopram Oral Solution
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
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
68999-729-10Escitalopram Oral Solution10 mL in 1 CUPSOLUTION101
68999-729-24Escitalopram Oral Solution2 in 1 BOXSOLUTION21
68999-729-24Escitalopram Oral Solution10 in 1 TRAYSOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68999-729-10ML - Milliliter68999-7292f3a70d2-3877-442e-97ae-8766ff511b9012026-03-17
68999-729-24ML - Milliliter68999-729669b7654-5dd5-4078-83b5-a2333fe9139a12026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351285escitalopram 5 MG in 5 mL Oral SolutionPSN45ed4d16-6358-40a1-9352-319e58f55e5d1
351285escitalopram 1 MG/ML Oral SolutionSCD45ed4d16-6358-40a1-9352-319e58f55e5d1
351285escitalopram (as escitalopram oxalate) 10 MG per 10 ML Oral SolutionSY45ed4d16-6358-40a1-9352-319e58f55e5d1
351285escitalopram (as escitalopram oxalate) 5 MG per 5 ML Oral SolutionSY45ed4d16-6358-40a1-9352-319e58f55e5d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68999-729-106899907291010 mL in 1 CUP10 mlHistorical
68999-729-24689990729242 TRAY in 1 BOX (68999-729-24) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (68999-729-10) 2 tray2026-01-21NoNoHistorical