Omega-3-acid Ethyl Esters (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 64380-761-11

Omega-3-Acid Ethyl Esters Capsules, USP

1 gram

120 Capsules

Rx only

container label
(click image for full-size original)
OMEGA-3-ACID ETHYL ESTERS omega-3-acid ethyl esters capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64380-761
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
GLYCERIN
GELATIN
SHELLAC
WATER
TITANIUM DIOXIDE
LECITHIN, SOYBEAN
BUTYL ALCOHOL
DIMETHICONE
Product Characteristics
Color YELLOW (pale yellow) Score no score
Shape CAPSULE (oblong) Size 24mm
Flavor Imprint Code 740
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64380-761-11 120 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203893 01/18/2019
Labeler — Strides Pharma Science Limited (650738743)
Registrant — Strides Pharma Science Limited (650738743)
Establishment
Name Address ID/FEI Operations
Strides Pharma Science Limited 918513263 ANALYSIS (64380-761), MANUFACTURE (64380-761), PACK (64380-761)

Revised: 11/2019 Strides Pharma Science Limited

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