Escitalopram (Page 10 of 10)

Principal Display Panel

NDC: 51655-449-52

Label
(click image for full-size original)
ESCITALOPRAM escitalopram tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-449(NDC:16729-169)
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
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (15000 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
Product Characteristics
Color white (White to off White) Score 2 pieces
Shape ROUND (biconvex) Size 8mm
Flavor Imprint Code 10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51655-449-52 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202389 10/20/2020
Labeler — Northwind Pharmaceuticals, LLC (036986393)
Registrant — Northwind Pharmaceuticals, LLC (036986393)
Establishment
Name Address ID/FEI Operations
Northwind Pharmaceuticals, LLC 036986393 repack (51655-449)

Revised: 08/2021 Northwind Pharmaceuticals, LLC

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