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

PRINCIPAL DISPLAY PANEL — 120 Capsule Bottle Label

NDC 51407-763-12

Omega-3-Acid
Ethyl Esters
Capsules, USP

1 gram*

Swallow capsules whole. Rx Only

120 Capsules

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OMEGA-3-ACID ETHYL ESTERS omega-3-acid ethyl esters capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-763(NDC:72998-851)
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 1 g
Inactive Ingredients
Ingredient Name Strength
.ALPHA.-TOCOPHEROL
GELATIN, UNSPECIFIED
GLYCERIN
WATER
Product Characteristics
Color white (Translucent) Score no score
Shape CAPSULE (Oblong) Size 25mm
Flavor Imprint Code GLW
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-763-12 120 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091028 04/07/2014
Labeler — Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply, Inc. 603184490 repack (51407-763), relabel (51407-763)

Revised: 02/2024 Golden State Medical Supply, Inc.

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