NDC 0378-3857

Escitalopram Oxalate

Escitalopram

Escitalopram Oxalate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Escitalopram Oxalate.

Product ID0378-3857_6404ddfe-f72d-4237-aea2-542cd677467e
NDC0378-3857
Product TypeHuman Prescription Drug
Proprietary NameEscitalopram Oxalate
Generic NameEscitalopram
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-02-29
Marketing End Date2020-01-31
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021323
Labeler NameMylan Pharmaceuticals Inc.
Substance NameESCITALOPRAM OXALATE
Active Ingredient Strength20 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN

Packaging

NDC 0378-3857-10

1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3857-10)
Marketing Start Date2012-02-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-3857-01 [00378385701]

Escitalopram Oxalate TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021323
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-02-29
Marketing End Date2014-09-05

NDC 0378-3857-93 [00378385793]

Escitalopram Oxalate TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021323
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-02-29
Marketing End Date2014-06-12

NDC 0378-3857-10 [00378385710]

Escitalopram Oxalate TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021323
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-02-29
Marketing End Date2020-01-31

NDC 0378-3857-77 [00378385777]

Escitalopram Oxalate TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021323
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-02-29
Marketing End Date2019-11-30

Drug Details

Active Ingredients

IngredientStrength
ESCITALOPRAM OXALATE20 mg/1

OpenFDA Data

SPL SET ID:9a6c8116-396d-413b-b8e7-5eb321781bd5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351250
  • 349332
  • 351249
  • Pharmacological Class

    • Serotonin Reuptake Inhibitor [EPC]
    • Serotonin Uptake Inhibitors [MoA]

    NDC Crossover Matching brand name "Escitalopram Oxalate" or generic name "Escitalopram"

    NDCBrand NameGeneric Name
    0121-0852Escitalopram OxalateEscitalopram Oxalate
    0378-3855Escitalopram Oxalateescitalopram
    0378-3856Escitalopram Oxalateescitalopram
    0378-3857Escitalopram Oxalateescitalopram
    68071-3283Escitalopram OxalateEscitalopram Oxalate
    68071-3312escitalopram oxalateescitalopram oxalate
    68071-3265escitalopram oxalateescitalopram oxalate
    68071-4210escitalopram oxalateescitalopram oxalate
    68645-519Escitalopram OxalateEscitalopram Oxalate
    68645-520Escitalopram OxalateEscitalopram Oxalate
    68788-6978escitalopram oxalateescitalopram oxalate
    69097-848Escitalopram OxalateEscitalopram Oxalate
    69097-849Escitalopram OxalateEscitalopram Oxalate
    69097-847Escitalopram OxalateEscitalopram Oxalate
    70518-0467escitalopram oxalateescitalopram oxalate
    70518-0472escitalopram oxalateescitalopram oxalate
    70518-0439escitalopram oxalateescitalopram oxalate
    70518-1315escitalopram oxalateescitalopram oxalate
    70518-0972Escitalopram OxalateEscitalopram Oxalate
    70518-0791escitalopram oxalateescitalopram oxalate
    70518-1291escitalopram oxalateescitalopram oxalate
    70518-1697escitalopram oxalateescitalopram oxalate
    70934-060escitalopram oxalateescitalopram oxalate
    70934-089escitalopram oxalateescitalopram oxalate
    70934-163escitalopram oxalateescitalopram oxalate
    71335-0685escitalopram oxalateescitalopram oxalate
    76282-251Escitalopram oxalateEscitalopram oxalate
    76282-249Escitalopram oxalateEscitalopram oxalate
    76282-250Escitalopram oxalateEscitalopram oxalate
    0904-6426escitalopram oxalateescitalopram oxalate
    0904-6427escitalopram oxalateescitalopram oxalate
    10544-968Escitalopram OxalateEscitalopram Oxalate
    10544-224escitalopram oxalateescitalopram oxalate
    10544-230escitalopram oxalateescitalopram oxalate
    10544-969Escitalopram OxalateEscitalopram Oxalate
    10544-225escitalopram oxalateescitalopram oxalate
    13668-135escitalopram oxalateescitalopram oxalate
    13668-137escitalopram oxalateescitalopram oxalate
    13668-136escitalopram oxalateescitalopram oxalate
    31722-569Escitalopram OxalateEscitalopram Oxalate
    33261-955escitalopram oxalateescitalopram oxalate
    33342-036Escitalopram OxalateEscitalopram Oxalate
    33342-038Escitalopram OxalateEscitalopram Oxalate
    33342-037Escitalopram OxalateEscitalopram Oxalate
    43063-761escitalopram oxalateescitalopram oxalate
    50090-2752escitalopram oxalateescitalopram oxalate
    51079-544Escitalopram OxalateEscitalopram Oxalate
    51079-543Escitalopram OxalateEscitalopram Oxalate
    55154-5386Escitalopram OxalateEscitalopram Oxalate
    54838-551Escitalopram OxalateEscitalopram Oxalate

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.