Omega-3-Acid Ethyl Ester (Page 4 of 4)

NDC 69452-175-22

Omega-3-Acid Ethyl Esters Capsules, USP 1 gram*

Swallow capsules whole.

Rx only

120 Capsules

BIONPHARMA

Container Label
(click image for full-size original)
OMEGA-3-ACID ETHYL ESTER
omega-3-acid ethyl esters capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69452-175
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEGA-3-ACID ETHYL ESTERS (OMEGA-3 FATTY ACIDS) OMEGA-3-ACID ETHYL ESTERS 900 mg
Inactive Ingredients
Ingredient Name Strength
ALPHA-TOCOPHEROL
GELATIN
GLYCERIN
ISOPROPYL ALCOHOL
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
PROPYLENE GLYCOL
WATER
Product Characteristics
Color yellow (light yellow) Score no score
Shape CAPSULE Size 25mm
Flavor Imprint Code 5038
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69452-175-17 60 CAPSULE, LIQUID FILLED in 1 BOTTLE None
2 NDC:69452-175-22 120 CAPSULE, LIQUID FILLED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206455 01/15/2017
Labeler — Bionpharma Inc. (079637826)
Registrant — Bionpharma Inc. (079637826)
Establishment
Name Address ID/FEI Operations
Patheon Softgels Inc. 002193829 manufacture (69452-175)

Revised: 05/2021 Bionpharma Inc.

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