ESCITALOPRAM- escitalopram tablet, film coated 
Cadila Healthcare Limited

----------

ESCITALOPRAM TABLETS

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

NDC 70771-1146-9 in bottle of 90 tablets

Escitalopram Oxalate Tablets USP, 10 mg

Rx only

90 tablets

Escitalopram Oxalate Tablets, 10 mg

NDC 70771-1147-9 in bottle of 90 tablets

Escitalopram Oxalate Tablets USP, 20 mg

Rx only

90 tablets

Escitalopram Oxalate Tablets, 20 mg
ESCITALOPRAM 
escitalopram tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1145
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESCITALOPRAM OXALATE (UNII: 5U85DBW7LO) (ESCITALOPRAM - UNII:4O4S742ANY) ESCITALOPRAM5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size6mm
FlavorImprint Code ZC;37
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1145-330 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
2NDC:70771-1145-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
3NDC:70771-1145-990 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
4NDC:70771-1145-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
5NDC:70771-1145-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07773412/07/2017
ESCITALOPRAM 
escitalopram tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1146
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESCITALOPRAM OXALATE (UNII: 5U85DBW7LO) (ESCITALOPRAM - UNII:4O4S742ANY) ESCITALOPRAM10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
ShapeROUND (ROUND) Size8mm
FlavorImprint Code ZC;23
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1146-330 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
2NDC:70771-1146-990 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
3NDC:70771-1146-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
4NDC:70771-1146-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
5NDC:70771-1146-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07773412/07/2017
ESCITALOPRAM 
escitalopram tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1147
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESCITALOPRAM OXALATE (UNII: 5U85DBW7LO) (ESCITALOPRAM - UNII:4O4S742ANY) ESCITALOPRAM20 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
ShapeROUND (ROUND) Size10mm
FlavorImprint Code ZC;24
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1147-330 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
2NDC:70771-1147-990 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
3NDC:70771-1147-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
4NDC:70771-1147-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
5NDC:70771-1147-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07773412/07/2017
Labeler - Cadila Healthcare Limited (918596198)

Revised: 8/2020
Document Id: 9eaea65c-dd42-435c-a93c-2173355ca331
Set id: 76d0e2a8-2ed2-4596-9179-8c360f4a0978
Version: 3
Effective Time: 20200826
 
Cadila Healthcare Limited