FDA.reportPublic FDA data

Escitalopram

Product NDC
55700-847
11-digit product format
557000847
Labeler code
55700
Product ID
55700-847_ce07bcac-80a7-47bf-a93d-8ef0c0a717ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA078032
Marketing category
ANDA
Marketing start
2020-03-06
Marketing end
2026-07-27
Substance
ESCITALOPRAM OXALATE
Active strength
10 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Escitalopram

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESCITALOPRAM OXALATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui349332

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
55700-847-30Escitalopram30 in 1 BOTTLETABLET, FILM COATED309
55700-847-60Escitalopram60 in 1 BOTTLETABLET, FILM COATED609
55700-847-90Escitalopram90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-847-30EA - Each55700-84790b6a543-441c-4657-9102-5c610dd4a5c312020-04-20
55700-847-60EA - Each55700-84706802a77-dc72-41df-bffd-429f7440ab5712020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-847ESCITALOPRAM TABLET, FILM COATED [QUALITY CARE PRODUCTS, LLC]9Current NDC, Legacy NDC, 3 package rows20241220_dffdb225-c87c-4182-87be-b6a20ae14c85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-847-305570008473030 TABLET, FILM COATED in 1 BOTTLE (55700-847-30) 2020-03-062026-07-27NoNoCurrent
55700-847-605570008476060 TABLET, FILM COATED in 1 BOTTLE (55700-847-60) 2020-03-060000-00-00NoNoCurrent
55700-847-905570008479090 TABLET, FILM COATED in 1 BOTTLE (55700-847-90) 2020-08-192026-07-27NoNoCurrent