NDC 64380-761

omega-3-acid ethyl esters

Omega-3-acid Ethyl Esters

omega-3-acid ethyl esters is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Strides Pharma Science Limited. The primary component is Omega-3-acid Ethyl Esters.

Product ID64380-761_1d85ecb3-258d-4eb3-a6ba-1639150ff267
NDC64380-761
Product TypeHuman Prescription Drug
Proprietary Nameomega-3-acid ethyl esters
Generic NameOmega-3-acid Ethyl Esters
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2019-01-18
Marketing CategoryANDA / ANDA
Application NumberANDA203893
Labeler NameStrides Pharma Science Limited
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 Through2021-12-31

Packaging

NDC 64380-761-11

120 CAPSULE in 1 BOTTLE (64380-761-11)
Marketing Start Date2019-01-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64380-761-11 [64380076111]

omega-3-acid ethyl esters CAPSULE
Marketing CategoryANDA
Application NumberANDA203893
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-01-18

Drug Details

Active Ingredients

IngredientStrength
OMEGA-3-ACID ETHYL ESTERS900 mg/1

OpenFDA Data

SPL SET ID:9499c40e-6665-4fbf-914d-1a9931b93562
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 577208

    • Pharmacological Class

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

    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
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