FDA.reportPublic FDA data

Escitalopram

Product NDC
71335-1307
11-digit product format
713351307
Labeler code
71335
Product ID
71335-1307_64a7bb93-6461-45c9-b5ca-610a25db5140
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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
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 OXALATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5U85DBW7LO
Rxcui351250

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
71335-1307-1Escitalopram60 in 1 BOTTLETABLET, FILM COATED60104
71335-1307-2Escitalopram28 in 1 BOTTLETABLET, FILM COATED28104
71335-1307-3Escitalopram30 in 1 BOTTLETABLET, FILM COATED30104
71335-1307-4Escitalopram90 in 1 BOTTLETABLET, FILM COATED90104
71335-1307-5Escitalopram120 in 1 BOTTLETABLET, FILM COATED120104
71335-1307-6Escitalopram100 in 1 BOTTLETABLET, FILM COATED100104
71335-1307-7Escitalopram45 in 1 BOTTLETABLET, FILM COATED45104
71335-1307-8Escitalopram180 in 1 BOTTLETABLET, FILM COATED180104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1307-1EA - Each71335-1307374510bb-8a8a-4cb6-b386-15a6fa9d41e812023-12-05
71335-1307-3EA - Each71335-13075c6e930a-ff78-4e1c-97c9-a6d22a4568d412019-12-10
71335-1307-4EA - Each71335-130761f60db3-2732-4efa-be27-f2b8a5231a7012023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1307ESCITALOPRAM TABLET, FILM COATED [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 8 package rows20240824_102c3893-4fdc-40b3-bd83-775e292723d7.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1307-17133513070160 TABLET, FILM COATED in 1 BOTTLE (71335-1307-1) 2020-02-060000-00-00NoNoCurrent
71335-1307-27133513070228 TABLET, FILM COATED in 1 BOTTLE (71335-1307-2) 2024-04-030000-00-00NoNoCurrent
71335-1307-37133513070330 TABLET, FILM COATED in 1 BOTTLE (71335-1307-3) 2019-08-220000-00-00NoNoCurrent
71335-1307-47133513070490 TABLET, FILM COATED in 1 BOTTLE (71335-1307-4) 2019-09-200000-00-00NoNoCurrent
71335-1307-571335130705120 TABLET, FILM COATED in 1 BOTTLE (71335-1307-5) 2020-06-290000-00-00NoNoCurrent
71335-1307-671335130706100 TABLET, FILM COATED in 1 BOTTLE (71335-1307-6) 2020-08-270000-00-00NoNoCurrent
71335-1307-77133513070745 TABLET, FILM COATED in 1 BOTTLE (71335-1307-7) 2024-04-030000-00-00NoNoCurrent
71335-1307-871335130708180 TABLET, FILM COATED in 1 BOTTLE (71335-1307-8) 2023-01-260000-00-00NoNoCurrent