NDC 65162-034

Omega-3-Acid Ethyl Esters

Omega-3-acid Ethyl Esters

Omega-3-Acid Ethyl Esters is a Oral Capsule, Liquid Filled in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Llc. The primary component is Omega-3-acid Ethyl Esters.

Product ID65162-034_1458d282-3306-4346-9125-a460bc150fbe
NDC65162-034
Product TypeHuman Prescription Drug
Proprietary NameOmega-3-Acid Ethyl Esters
Generic NameOmega-3-acid Ethyl Esters
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2015-11-30
Marketing CategoryANDA / ANDA
Application NumberANDA204940
Labeler NameAmneal Pharmaceuticals LLC
Substance NameOMEGA-3-ACID ETHYL ESTERS
Active Ingredient Strength1 g/1
Pharm ClassesFatty Acids, Omega-3 [CS], Omega-3 Fatty Acid [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 65162-034-06

60 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-034-06)
Marketing Start Date2015-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65162-034-06 [65162003406]

Omega-3-Acid Ethyl Esters CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA204940
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-11-30

NDC 65162-034-32 [65162003432]

Omega-3-Acid Ethyl Esters CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA204940
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-11-30

NDC 65162-034-16 [65162003416]

Omega-3-Acid Ethyl Esters CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA204940
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-11-30

Drug Details

Active Ingredients

IngredientStrength
OMEGA-3-ACID ETHYL ESTERS1 g/1

OpenFDA Data

SPL SET ID:530161f4-26a0-4cb0-8a01-a18cfd36d88c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 577208
    • UPC Code
  • 0365162034066

    • Pharmacological Class

    • Fatty Acids
    • Omega-3 [CS]
    • Omega-3 Fatty Acid [EPC]

    Medicade Reported Pricing

    65162034784 ZENCHENT FE TABLET CHEWABLE

    Pricing Unit: EA | Drug Type:

    65162003416 OMEGA-3 ETHYL ESTERS 1 GM CAP

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Omega-3-Acid Ethyl Esters" or generic name "Omega-3-acid Ethyl Esters"

    NDCBrand NameGeneric Name
    0093-5401Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl Esters
    0254-3010Omega-3-acid ethyl estersOmega-3-acid ethyl esters
    0904-6706Omega-3-acid ethyl estersOmega-3-acid ethyl esters
    16714-660Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl Esters
    17856-0034Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl Esters
    31722-936Omega-3-acid ethyl estersOmega-3-acid ethyl esters
    42291-657Omega-3-acid ethyl estersOmega-3-acid ethyl esters
    42708-067Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl Esters
    42806-552OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERS
    49884-019Omega-3-Acid Ethyl Estersomega-3-acid ethyl esters
    50090-3421Omega-3-acid ethyl estersOmega-3-acid ethyl esters
    50090-3742Omega-3-acid ethyl estersOmega-3-acid ethyl esters
    50090-3956Omega-3-Acid Ethyl Estersomega-3-acid ethyl esters
    50090-3957Omega-3-Acid Ethyl Estersomega-3-acid ethyl esters
    50090-5799Omega-3-acid ethyl estersOmega-3-acid ethyl esters
    50268-676omega-3-acid ethyl estersomega-3-acid ethyl esters
    55700-873Omega-3-acid ethyl estersOmega-3-acid ethyl esters
    60429-912Omega-3-Acid Ethyl Estersomega-3-acid ethyl esters
    60505-3170Omega-3-acid ethyl estersOmega-3-acid ethyl esters
    69837-170OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERS
    70518-1636Omega-3-acid ethyl estersOmega-3-acid ethyl esters
    60687-127Omega-3-acid ethyl estersOmega-3-acid ethyl esters
    60505-4462Omega-3-acid ethyl estersOmega-3-acid ethyl esters
    63629-6805Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl Esters
    64380-761omega-3-acid ethyl estersomega-3-acid ethyl esters
    65162-034Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl Esters
    66993-839Omega-3-acid ethyl estersOmega-3-acid ethyl esters
    66993-726Omega-3-acid ethyl estersOmega-3-acid ethyl esters
    72189-024OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERS
    62559-410Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl Esters
    70518-2319Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl Esters
    72865-139OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERS
    63629-1918Omega-3-acid ethyl estersOmega-3-acid ethyl esters
    0173-0783LOVAZAomega-3-acid ethyl esters
    0173-0884LOVAZAomega-3-acid ethyl esters
    17856-0084LOVAZAomega-3-acid ethyl esters
    17856-0783LOVAZAomega-3-acid ethyl esters
    21695-795LOVAZAomega-3-acid ethyl esters
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.