NDC Code(s) : 72162-1310-2
Packager : Bryant Ranch Prepack

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Omega-3-acid ethyl esters Omega-3-acid ethyl esters CAPSULE, LIQUID FILLED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72162-1310(NDC:31722-936)
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)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
SOYBEAN OIL(UNII: 241ATL177A)
WATER(UNII: 059QF0KO0R)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
Product Characteristics
Color yellow Score no score
Shape OVAL (Oblong) Size 24 mm
Flavor Imprint Code AT132
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72162-1310-2120 in 1 BOTTLE Type 0: Not a Combination Product10/06/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207420 02/25/2019

LABELER - Bryant Ranch Prepack(171714327)

REGISTRANT - Bryant Ranch Prepack(171714327)

Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK(72162-1310), RELABEL(72162-1310)

PRINCIPAL DISPLAY PANEL

Omega-3-Acid Ethyl Esters 1 g Cap#120

Label