NDC Code(s) : 42806-552-12
Packager : EPIC PHARMA, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42806-552
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEGA-3-ACID ETHYL ESTERS(UNII: D87YGH4Z0Q)
(OMEGA-3 FATTY ACIDS - UNII:71M78END5S) 		OMEGA-3-ACID ETHYL ESTERS1 g
Inactive Ingredients
Ingredient Name Strength
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
GLYCERIN(UNII: PDC6A3C0OX)
WATER(UNII: 059QF0KO0R)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color YELLOW (light yellow) Score no score
Shape CAPSULE Size 25 mm
Flavor Imprint Code PC25
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42806-552-12120 in 1 BOTTLE Type 0: Not a Combination Product07/02/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210093 07/02/2020

LABELER - EPIC PHARMA, LLC(827915443)

REGISTRANT - Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd(421293287)

Establishment
Name Address ID/FEI Business Operations
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd 421293287 MANUFACTURE(42806-552)

PRINCIPAL DISPLAY PANEL

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