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

Rx only

90 tablets

Escitalopram Oxalate Tablets, 5 mg
(click image for full-size original)

NDC 70771-1146-9 in bottle of 90 tablets

Escitalopram Oxalate Tablets USP, 10 mg

Rx only

90 tablets

Escitalopram Oxalate Tablets, 10 mg
(click image for full-size original)

NDC 70771-1147-9 in bottle of 90 tablets

Escitalopram Oxalate Tablets USP, 20 mg

Rx only

90 tablets

Escitalopram Oxalate Tablets, 20 mg
(click image for full-size original)
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

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