escitalopram

Product NDC
71335-2331
11-digit product format
713352331
Labeler code
71335
Product ID
71335-2331_21ac3cbd-f221-40b7-b2b9-019bc9ef1988
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078777
Marketing category
ANDA
Marketing start
2023-06-10
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

openFDA Listing Details

Product ID
71335-2331_21ac3cbd-f221-40b7-b2b9-019bc9ef1988
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
escitalopram
Generic name
escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Marketing start
2023-06-10
Marketing category
ANDA
Application number
ANDA078777
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]; Serotonin Uptake Inhibitors [MoA]
Listing expiration
2026-12-31

Related Records

openFDA Active Ingredients

IngredientStrength
ESCITALOPRAM OXALATE20 mg/1

openFDA Harmonized Identifiers

FieldValues
Unii5U85DBW7LO
Rxcui351250
Spl Set Id735a138b-fff3-4ed0-8a51-9090cf88ba30
Manufacturer NameBryant Ranch Prepack

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
5U85DBW7LOESCITALOPRAM OXALATE219861-08-2ESCITALOPRAM OXALATE
4O4S742ANYESCITALOPRAM128196-01-0escitalopram

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2331-17133523310160 TABLET, FILM COATED in 1 BOTTLE (71335-2331-1) 2024-12-11NoNoCurrent
71335-2331-27133523310228 TABLET, FILM COATED in 1 BOTTLE (71335-2331-2) 2024-12-11NoNoCurrent
71335-2331-37133523310330 TABLET, FILM COATED in 1 BOTTLE (71335-2331-3) 2024-02-14NoNoCurrent
71335-2331-47133523310490 TABLET, FILM COATED in 1 BOTTLE (71335-2331-4) 2024-02-09NoNoCurrent
71335-2331-571335233105120 TABLET, FILM COATED in 1 BOTTLE (71335-2331-5) 2024-12-11NoNoCurrent
71335-2331-671335233106100 TABLET, FILM COATED in 1 BOTTLE (71335-2331-6) 2024-05-28NoNoCurrent
71335-2331-77133523310745 TABLET, FILM COATED in 1 BOTTLE (71335-2331-7) 2024-12-11NoNoCurrent
71335-2331-871335233108180 TABLET, FILM COATED in 1 BOTTLE (71335-2331-8) 2024-12-11NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
escitalopramBryant Ranch Prepack2024-12-11HUMAN PRESCRIPTION DRUG LABEL101