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Escitalopram - Prescription Drug Labeling

Product NDC Code 70771-1146
Drug Name

Escitalopram

Type Generic
Pharm Class Serotonin Reuptake Inhibitor [EPC],
Serotonin Uptake Inhibitors [MoA]
Active Ingredients
Escitalopram oxalate 10 mg/1
Route ORAL
Dosage Form TABLET, FILM COATED
RxCUI drug identifier 349332,
351249,
351250
Application Number ANDA077734
Labeler Name Zydus Lifesciences Limited
Packages
Package NDC Code Description
70771-1146-0 1000 tablet, film coated in 1 bottle (70771-1146-0)
70771-1146-1 100 tablet, film coated in 1 bottle (70771-1146-1)
70771-1146-3 30 tablet, film coated in 1 bottle (70771-1146-3)
70771-1146-5 500 tablet, film coated in 1 bottle (70771-1146-5)
70771-1146-9 90 tablet, film coated in 1 bottle (70771-1146-9)

Spl product data elements

Usually a list of ingredients in a drug product.
escitalopram escitalopram ESCITALOPRAM OXALATE ESCITALOPRAM SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE TALC TITANIUM DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED WHITE TO OFF-WHITE ROUND ZC;37 escitalopram escitalopram ESCITALOPRAM OXALATE ESCITALOPRAM SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE TALC TITANIUM DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED WHITE TO OFF-WHITE ROUND ZC;23 escitalopram escitalopram ESCITALOPRAM OXALATE ESCITALOPRAM SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE TALC TITANIUM DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED WHITE TO OFF-WHITE ROUND ZC;24

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1145-9 in bottle of 90 tablets Escitalopram Oxalate Tablets USP, 5 mg R x only 90 tablets NDC 70771-1146-9 in bottle of 90 tablets Escitalopram Oxalate Tablets USP, 10 mg R x only 90 tablets NDC 70771-1147-9 in bottle of 90 tablets Escitalopram Oxalate Tablets USP, 20 mg R x only 90 tablets Escitalopram Oxalate Tablets, 5 mg Escitalopram Oxalate Tablets, 10 mg Escitalopram Oxalate Tablets, 20 mg

Spl medguide

Information about the patient medication guide that accompanies the drug product. Certain drugs must be dispensed with an accompanying medication guide. This field may contain information about when to consult the medication guide and the contents of the medication guide.
SPL MEDGUIDE Manufactured by: Cadila Healthcare Ltd. India.

Disclaimer: Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API