FDA.reportPublic FDA data

Escitalopram

Product NDC
43547-281
11-digit product format
435470281
Labeler code
43547
Product ID
43547-281_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
10 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 OXALATE10 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
43547-281-10Escitalopram100 in 1 BOTTLETABLET, FILM COATED10018
43547-281-11Escitalopram1000 in 1 BOTTLETABLET, FILM COATED100018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-281-10EA - Each43547-281ffa6b28d-5275-467d-9cb0-b34dd42c07b612016-03-04
43547-281-11EA - Each43547-2814e25b0b1-e710-48ae-874a-32ab440ff0c012016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-281ESCITALOPRAM 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
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
349332escitalopram oxalate 10 MG Oral TabletPSNb6fbd554-9da7-40fd-87a5-2c4af2aa3e6c13
349332escitalopram 10 MG Oral TabletSCDb6fbd554-9da7-40fd-87a5-2c4af2aa3e6c13
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYb6fbd554-9da7-40fd-87a5-2c4af2aa3e6c13
349332escitalopram oxalate 10 MG Oral TabletPSNc842ec12-8792-47a9-82ad-9edf99e549ba10
349332escitalopram 10 MG Oral TabletSCDc842ec12-8792-47a9-82ad-9edf99e549ba10
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYc842ec12-8792-47a9-82ad-9edf99e549ba10
349332escitalopram oxalate 10 MG Oral TabletPSNdffdb225-c87c-4182-87be-b6a20ae14c859
349332escitalopram 10 MG Oral TabletSCDdffdb225-c87c-4182-87be-b6a20ae14c859
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYdffdb225-c87c-4182-87be-b6a20ae14c859
349332escitalopram oxalate 10 MG Oral TabletPSNa0344290-6e12-46c4-a11c-5347a770adbe7
349332escitalopram 10 MG Oral TabletSCDa0344290-6e12-46c4-a11c-5347a770adbe7
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYa0344290-6e12-46c4-a11c-5347a770adbe7
349332escitalopram oxalate 10 MG Oral TabletPSNb34c345f-07f1-4f36-e053-2995a90ab7176
349332escitalopram 10 MG Oral TabletSCDb34c345f-07f1-4f36-e053-2995a90ab7176
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYb34c345f-07f1-4f36-e053-2995a90ab7176
349332escitalopram oxalate 10 MG Oral TabletPSNe56e8d41-188c-5a6f-e053-2a95a90a70e65
349332escitalopram 10 MG Oral TabletSCDe56e8d41-188c-5a6f-e053-2a95a90a70e65
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYe56e8d41-188c-5a6f-e053-2a95a90a70e65
349332escitalopram oxalate 10 MG Oral TabletPSNf2b7b0a6-481b-1f6f-e053-2a95a90a2d044
349332escitalopram 10 MG Oral TabletSCDf2b7b0a6-481b-1f6f-e053-2a95a90a2d044
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYf2b7b0a6-481b-1f6f-e053-2a95a90a2d044
349332escitalopram oxalate 10 MG Oral TabletPSNba6a0c20-4915-4164-a39e-ca67d652cbfd3
349332escitalopram oxalate 10 MG Oral TabletPSNf435d670-87ff-f226-e053-2a95a90ac0ee3
349332escitalopram 10 MG Oral TabletSCDba6a0c20-4915-4164-a39e-ca67d652cbfd3
349332escitalopram 10 MG Oral TabletSCDf435d670-87ff-f226-e053-2a95a90ac0ee3
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYba6a0c20-4915-4164-a39e-ca67d652cbfd3
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYf435d670-87ff-f226-e053-2a95a90ac0ee3
349332escitalopram oxalate 10 MG Oral TabletPSNf914fec5-4ce7-794d-e053-6294a90a7cc52
349332escitalopram 10 MG Oral TabletSCDf914fec5-4ce7-794d-e053-6294a90a7cc52
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYf914fec5-4ce7-794d-e053-6294a90a7cc52
349332escitalopram oxalate 10 MG Oral TabletPSNa8535762-0e73-69d8-e053-2a95a90aafba1
349332escitalopram oxalate 10 MG Oral TabletPSN5088d6cd-ec13-384d-e063-6394a90aee051
349332escitalopram oxalate 10 MG Oral TabletPSN3e3de8ea-b96b-456b-9336-69380fd2d0581
349332escitalopram oxalate 10 MG Oral TabletPSN071b592e-0938-4473-8f4d-9f8cafa7a8b71
349332escitalopram 10 MG Oral TabletSCDa8535762-0e73-69d8-e053-2a95a90aafba1
349332escitalopram 10 MG Oral TabletSCD5088d6cd-ec13-384d-e063-6394a90aee051
349332escitalopram 10 MG Oral TabletSCD3e3de8ea-b96b-456b-9336-69380fd2d0581
349332escitalopram 10 MG Oral TabletSCD071b592e-0938-4473-8f4d-9f8cafa7a8b71
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSYa8535762-0e73-69d8-e053-2a95a90aafba1
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY5088d6cd-ec13-384d-e063-6394a90aee051
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY3e3de8ea-b96b-456b-9336-69380fd2d0581
349332escitalopram (as escitalopram oxalate) 10 MG Oral TabletSY071b592e-0938-4473-8f4d-9f8cafa7a8b71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43547-281-1043547028110100 TABLET, FILM COATED in 1 BOTTLE (43547-281-10) 2016-02-010000-00-00NoNoCurrent
43547-281-11435470281111000 TABLET, FILM COATED in 1 BOTTLE (43547-281-11) 2016-02-010000-00-00NoNoCurrent