FDA.reportPublic FDA data

Escitalopram

Product NDC
43547-282
11-digit product format
435470282
Labeler code
43547
Product ID
43547-282_9eb8b7e7-53d7-461e-86e5-670262dad840
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
SOLCO HEALTHCARE US, LLC
Application
ANDA078032
Marketing category
ANDA
Marketing start
2016-02-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Escitalopram
Listing expiration
2027-12-31

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615Product name620170718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-282-10Escitalopram100 in 1 BOTTLETABLET, FILM COATED10018
43547-282-11Escitalopram1000 in 1 BOTTLETABLET, FILM COATED100018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-282-10EA - Each43547-28242737665-ee3b-4ea7-b28d-d97c06aad68312016-04-04
43547-282-11EA - Each43547-2825e708acc-645d-4ca9-b495-45153981fea912016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-282ESCITALOPRAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]14Current NDC, Legacy NDC, 2 package rows20240831_155e973a-f4ff-4e5a-b937-09f1e106fe39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351250escitalopram oxalate 20 MG Oral TabletPSN102c3893-4fdc-40b3-bd83-775e292723d7104
351250escitalopram 20 MG Oral TabletSCD102c3893-4fdc-40b3-bd83-775e292723d7104
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY102c3893-4fdc-40b3-bd83-775e292723d7104
349332escitalopram oxalate 10 MG Oral TabletPSN155e973a-f4ff-4e5a-b937-09f1e106fe3918
351250escitalopram oxalate 20 MG Oral TabletPSN155e973a-f4ff-4e5a-b937-09f1e106fe3918
351249escitalopram oxalate 5 MG Oral TabletPSN155e973a-f4ff-4e5a-b937-09f1e106fe3918
349332escitalopram 10 MG Oral TabletSCD155e973a-f4ff-4e5a-b937-09f1e106fe3918
351250escitalopram 20 MG Oral TabletSCD155e973a-f4ff-4e5a-b937-09f1e106fe3918
351249escitalopram 5 MG Oral TabletSCD155e973a-f4ff-4e5a-b937-09f1e106fe3918
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY155e973a-f4ff-4e5a-b937-09f1e106fe3918
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY155e973a-f4ff-4e5a-b937-09f1e106fe3918
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY155e973a-f4ff-4e5a-b937-09f1e106fe3918
351250escitalopram oxalate 20 MG Oral TabletPSN3e3a3e36-fb2f-4d9b-bbcf-423bd97c9f887
351250escitalopram oxalate 20 MG Oral TabletPSN34d14a62-3bdd-405c-82e6-a03302b298607
351250escitalopram 20 MG Oral TabletSCD34d14a62-3bdd-405c-82e6-a03302b298607
351250escitalopram 20 MG Oral TabletSCD3e3a3e36-fb2f-4d9b-bbcf-423bd97c9f887
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY3e3a3e36-fb2f-4d9b-bbcf-423bd97c9f887
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY34d14a62-3bdd-405c-82e6-a03302b298607
351250escitalopram oxalate 20 MG Oral TabletPSNaddccf96-cc60-6045-e053-2a95a90aaac06
351250escitalopram 20 MG Oral TabletSCDaddccf96-cc60-6045-e053-2a95a90aaac06
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYaddccf96-cc60-6045-e053-2a95a90aaac06
351250escitalopram oxalate 20 MG Oral TabletPSNa489600b-6ae0-edb7-e053-2a95a90a7d004
351250escitalopram oxalate 20 MG Oral TabletPSN575d7755-0518-4d48-bb1a-4ad01321fde74
351250escitalopram oxalate 20 MG Oral TabletPSNf682f991-1807-176a-e053-2995a90a3dfa4
351250escitalopram 20 MG Oral TabletSCD575d7755-0518-4d48-bb1a-4ad01321fde74
351250escitalopram 20 MG Oral TabletSCDa489600b-6ae0-edb7-e053-2a95a90a7d004
351250escitalopram 20 MG Oral TabletSCDf682f991-1807-176a-e053-2995a90a3dfa4
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYa489600b-6ae0-edb7-e053-2a95a90a7d004
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYf682f991-1807-176a-e053-2995a90a3dfa4
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY575d7755-0518-4d48-bb1a-4ad01321fde74
351250escitalopram oxalate 20 MG Oral TabletPSNbb66252e-3a0f-7240-e053-2a95a90acfd93
351250escitalopram oxalate 20 MG Oral TabletPSN2ffc6ec3-830f-46bc-9b3f-7c42cefa39b23
351250escitalopram oxalate 20 MG Oral TabletPSNf81e3858-f01e-1df6-e053-6394a90aef4f3
351250escitalopram 20 MG Oral TabletSCD2ffc6ec3-830f-46bc-9b3f-7c42cefa39b23
351250escitalopram 20 MG Oral TabletSCDbb66252e-3a0f-7240-e053-2a95a90acfd93
351250escitalopram 20 MG Oral TabletSCDf81e3858-f01e-1df6-e053-6394a90aef4f3
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYbb66252e-3a0f-7240-e053-2a95a90acfd93
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSY2ffc6ec3-830f-46bc-9b3f-7c42cefa39b23
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYf81e3858-f01e-1df6-e053-6394a90aef4f3
351250escitalopram oxalate 20 MG Oral TabletPSNfc61822a-4058-343c-e053-6294a90af72c2
351250escitalopram oxalate 20 MG Oral TabletPSNdb93c6f1-d541-40eb-8836-702c952f47732
351250escitalopram 20 MG Oral TabletSCDfc61822a-4058-343c-e053-6294a90af72c2
351250escitalopram 20 MG Oral TabletSCDdb93c6f1-d541-40eb-8836-702c952f47732
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYfc61822a-4058-343c-e053-6294a90af72c2
351250escitalopram (as escitalopram oxalate) 20 MG Oral TabletSYdb93c6f1-d541-40eb-8836-702c952f47732

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43547-282-1043547028210100 TABLET, FILM COATED in 1 BOTTLE (43547-282-10) 2016-02-010000-00-00NoNoCurrent
43547-282-11435470282111000 TABLET, FILM COATED in 1 BOTTLE (43547-282-11) 2016-02-010000-00-00NoNoCurrent