NDC 69452-175

Omega-3-Acid Ethyl Ester

Omega-3-acid Ethyl Esters

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

Product ID69452-175_a68e3596-d140-47dd-8065-783bf98cf622
NDC69452-175
Product TypeHuman Prescription Drug
Proprietary NameOmega-3-Acid Ethyl Ester
Generic NameOmega-3-acid Ethyl Esters
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2019-10-15
Marketing CategoryANDA / ANDA
Application NumberANDA206455
Labeler NameBionpharma Inc.
Substance NameOMEGA-3-ACID ETHYL ESTERS
Active Ingredient Strength900 mg/1
Pharm ClassesFatty Acids, Omega-3 [CS],Omega-3 Fatty Acid [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 69452-175-17

60 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-175-17)
Marketing Start Date2017-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69452-175-17 [69452017517]

Omega-3-Acid Ethyl Ester CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA206455
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-10-15

NDC 69452-175-22 [69452017522]

Omega-3-Acid Ethyl Ester CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA206455
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-10-15

Drug Details

Active Ingredients

IngredientStrength
OMEGA-3-ACID ETHYL ESTERS900 mg/1

OpenFDA Data

SPL SET ID:91ef2e89-e816-4494-9558-2f647b7452f8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 577208

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    69452-175Omega-3-Acid Ethyl EsterOmega-3-Acid Ethyl Ester
    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
    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
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