FDA.reportPublic FDA data

Escitalopram

Product NDC
43547-280
11-digit product format
435470280
Labeler code
43547
Product ID
43547-280_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
5 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 OXALATE5 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
43547-280-10Escitalopram100 in 1 BOTTLETABLET, FILM COATED10018
43547-280-11Escitalopram1000 in 1 BOTTLETABLET, FILM COATED100018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-280-10EA - Each43547-2803e6f0b4a-4379-4e62-8582-ff412451b98812016-03-04
43547-280-11EA - Each43547-280647cce0c-db1a-4809-98c6-1b0cf542b1a012016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-280ESCITALOPRAM 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
351249escitalopram oxalate 5 MG Oral TabletPSN20281fe6-7db9-4b33-8418-b25e6a5404ca103
351249escitalopram 5 MG Oral TabletSCD20281fe6-7db9-4b33-8418-b25e6a5404ca103
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY20281fe6-7db9-4b33-8418-b25e6a5404ca103
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
351249escitalopram oxalate 5 MG Oral TabletPSN83a642b9-acee-45d3-95a1-52a491b770fd14
351249escitalopram 5 MG Oral TabletSCD83a642b9-acee-45d3-95a1-52a491b770fd14
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY83a642b9-acee-45d3-95a1-52a491b770fd14
351249escitalopram oxalate 5 MG Oral TabletPSNb9453a53-93ac-b103-e053-2995a90a18ff7
351249escitalopram 5 MG Oral TabletSCDb9453a53-93ac-b103-e053-2995a90a18ff7
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSYb9453a53-93ac-b103-e053-2995a90a18ff7
351249escitalopram oxalate 5 MG Oral TabletPSN9b0b3c54-5bbc-4db9-9c69-00dac1347f245
351249escitalopram oxalate 5 MG Oral TabletPSNf2b3b385-658d-5918-e053-2a95a90afcba5
351249escitalopram 5 MG Oral TabletSCD9b0b3c54-5bbc-4db9-9c69-00dac1347f245
351249escitalopram 5 MG Oral TabletSCDf2b3b385-658d-5918-e053-2a95a90afcba5
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSY9b0b3c54-5bbc-4db9-9c69-00dac1347f245
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSYf2b3b385-658d-5918-e053-2a95a90afcba5
351249escitalopram oxalate 5 MG Oral TabletPSNf75aabf8-f4a1-acd1-e053-6294a90ab9a62
351249escitalopram 5 MG Oral TabletSCDf75aabf8-f4a1-acd1-e053-6294a90ab9a62
351249escitalopram (as escitalopram oxalate) 5 MG Oral TabletSYf75aabf8-f4a1-acd1-e053-6294a90ab9a62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43547-280-1043547028010100 TABLET, FILM COATED in 1 BOTTLE (43547-280-10) 2016-02-010000-00-00NoNoCurrent
43547-280-11435470280111000 TABLET, FILM COATED in 1 BOTTLE (43547-280-11) 2016-02-010000-00-00NoNoCurrent