Escitalopram (Page 9 of 9)

Escitalopram Tablets USP 10 mg

LC0073 EAE

Escitalopram
(click image for full-size original)

Escitalopram

Escitalopram Tablets USP 20 mg

LC0074 EAE

Escitalopram
(click image for full-size original)

Escitalopram

ESCITALOPRAM
escitalopram tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54458-892(NDC:0093-5851)
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
STARCH, CORN
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (15 MPA.S)
MAGNESIUM STEARATE
MANNITOL
CELLULOSE, MICROCRYSTALLINE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 6000
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code 5851;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54458-892-10 30 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076765 09/19/2013
ESCITALOPRAM
escitalopram tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54458-891(NDC:0093-5852)
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
STARCH, CORN
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (15 MPA.S)
MAGNESIUM STEARATE
MANNITOL
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 6000
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code 5852;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54458-891-10 30 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076765 09/20/2013
Labeler — International Labs, Inc. (023569924)
Establishment
Name Address ID/FEI Operations
International Labs, Inc. 023569924 RELABEL (54458-892), RELABEL (54458-891), REPACK (54458-892), REPACK (54458-891)

Revised: 06/2015 International Labs, Inc.

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