FDA.reportPublic FDA data

Escitalopram

Product NDC
68001-591
11-digit product format
680010591
Labeler code
68001
Product ID
68001-591_3f619ebc-6f45-5959-e063-6294a90a61af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA078032
Marketing category
ANDA
Marketing start
2023-12-18
Substance
ESCITALOPRAM OXALATE
Active strength
5 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESCITALOPRAM OXALATE5 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
68001-591-00Escitalopram100 in 1 BOTTLETABLET, FILM COATED1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-591-00EA - Each68001-591cc9e6d42-4374-4958-a046-0619c2f7735712023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-591ESCITALOPRAM TABLET, FILM COATED [BLUEPOINT LABORATORIES]4Current NDC, 1 package rows20241211_d31c02d0-81d9-4aa4-bde9-52135aa5a66d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349332escitalopram oxalate 10 MG Oral TabletPSNd31c02d0-81d9-4aa4-bde9-52135aa5a66d5
351250escitalopram oxalate 20 MG Oral TabletPSNd31c02d0-81d9-4aa4-bde9-52135aa5a66d5
351249escitalopram oxalate 5 MG Oral TabletPSNd31c02d0-81d9-4aa4-bde9-52135aa5a66d5
349332escitalopram 10 MG Oral TabletSCDd31c02d0-81d9-4aa4-bde9-52135aa5a66d5
351250escitalopram 20 MG Oral TabletSCDd31c02d0-81d9-4aa4-bde9-52135aa5a66d5
351249escitalopram 5 MG Oral TabletSCDd31c02d0-81d9-4aa4-bde9-52135aa5a66d5
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYd31c02d0-81d9-4aa4-bde9-52135aa5a66d5
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYd31c02d0-81d9-4aa4-bde9-52135aa5a66d5
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSYd31c02d0-81d9-4aa4-bde9-52135aa5a66d5
351249escitalopram oxalate 5 MG Oral TabletPSNde803217-6d32-4ef8-afe7-02462f37bf0c2
351249escitalopram 5 MG Oral TabletSCDde803217-6d32-4ef8-afe7-02462f37bf0c2
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSYde803217-6d32-4ef8-afe7-02462f37bf0c2
351249escitalopram oxalate 5 MG Oral TabletPSN26a61b65-ee09-4b18-e063-6394a90ae8a61
351249escitalopram 5 MG Oral TabletSCD26a61b65-ee09-4b18-e063-6394a90ae8a61
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY26a61b65-ee09-4b18-e063-6394a90ae8a61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68001-591-0068001059100100 TABLET, FILM COATED in 1 BOTTLE (68001-591-00) 2023-12-18NoNoCurrent