NDC Code(s) : 52125-691-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

EscitalopramEscitalopram TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-691(NDC:0093-5851)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESCITALOPRAM OXALATE(UNII: 5U85DBW7LO)
(ESCITALOPRAM - UNII:4O4S742ANY) 		ESCITALOPRAM10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape ROUND Size 8 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-691-0230 in 1 BLISTER PACK Type 0: Not a Combination Product30/08/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076765 08/30/2013

PRINCIPAL DISPLAY PANEL

DRUG: Escitalopram

GENERIC: Escitalopram

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 52125-691-02

COLOR: white

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 8 mm

IMPRINT: 5851;10

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • ESCITALOPRAM OXALATE 10mg in 1

INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • MAGNESIUM STEARATE
  • MANNITOL
  • POLYETHYLENE GLYCOL 6000
  • CROSCARMELLOSE SODIUM
  • HYPROMELLOSE 2910 (15 MPA.S)
  • STARCH, CORN
  • TITANIUM DIOXIDE

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