Escitalopram Oxalate (Page 11 of 11)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70934-060-30

Label
(click image for full-size original)
ESCITALOPRAM OXALATE escitalopram oxalate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70934-060(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
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
POVIDONE
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
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70934-060-30 30 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090939 10/14/2019
Labeler — Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)
Registrant — Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)
Establishment
Name Address ID/FEI Operations
Denton Pharma, Inc. DBA Northwind Pharmaceuticals 080355546 repack (70934-060)

Revised: 01/2022 Denton Pharma, Inc. DBA Northwind Pharmaceuticals

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