Escitalopram

ESCITALOPRAM- escitalopram oxalate tablet, film coated
Cadila Healthcare Limited

SPL MEDGUIDE

Manufactured by:

Cadila Healthcare Ltd.

India.

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 escitalopram tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1145 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESCITALOPRAM OXALATE (ESCITALOPRAM) ESCITALOPRAM 5 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE TALC TITANIUM DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED

Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 6mm Flavor Imprint Code ZC;37 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70771-1145-3 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:70771-1145-1 100 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:70771-1145-9 90 TABLET, FILM COATED in 1 BOTTLE None 4 NDC:70771-1145-5 500 TABLET, FILM COATED in 1 BOTTLE None 5 NDC:70771-1145-0 1000 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077734 12/07/2017

ESCITALOPRAM escitalopram tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1146 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESCITALOPRAM OXALATE (ESCITALOPRAM) ESCITALOPRAM 10 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE TALC TITANIUM DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED

Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score 2 pieces Shape ROUND (ROUND) Size 8mm Flavor Imprint Code ZC;23 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70771-1146-3 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:70771-1146-9 90 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:70771-1146-1 100 TABLET, FILM COATED in 1 BOTTLE None 4 NDC:70771-1146-5 500 TABLET, FILM COATED in 1 BOTTLE None 5 NDC:70771-1146-0 1000 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077734 12/07/2017

ESCITALOPRAM escitalopram tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1147 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESCITALOPRAM OXALATE (ESCITALOPRAM) ESCITALOPRAM 20 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE TALC TITANIUM DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED

Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score 2 pieces Shape ROUND (ROUND) Size 10mm Flavor Imprint Code ZC;24 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70771-1147-3 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:70771-1147-9 90 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:70771-1147-1 100 TABLET, FILM COATED in 1 BOTTLE None 4 NDC:70771-1147-5 500 TABLET, FILM COATED in 1 BOTTLE None 5 NDC:70771-1147-0 1000 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077734 12/07/2017

Labeler — Cadila Healthcare Limited (918596198)

Revised: 08/2020 Cadila Healthcare Limited