Escitalopram Oxalate (Page 10 of 10)

Package/Label Display Panel

Escitalopram Tablets, USP

10 mg

100 Tablets

Carton Label
(click image for full-size original)

Package/Label Display Panel

Escitalopram Tablets, USP

20 mg

100 Tablets

Carton Label
(click image for full-size original)
ESCITALOPRAM OXALATE escitalopram oxalate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6426(NDC:13668-136)
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
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
POVIDONE K12
TALC
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (white) Score 2 pieces
Shape ROUND (Round) Size 8mm
Flavor Imprint Code 11;36;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-6426-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0904-6426-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090939 10/15/2014
ESCITALOPRAM OXALATE escitalopram oxalate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6427(NDC:13668-137)
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
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
POVIDONE K12
TALC
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (white) Score 2 pieces
Shape ROUND (Round) Size 10mm
Flavor Imprint Code 11;37;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-6427-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0904-6427-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090939 10/15/2014
Labeler — Major Pharmaceuticals (191427277)

Revised: 11/2019 Major Pharmaceuticals

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