NDC 70518-2167

Prilosec OTC

Omeprazole Magnesium

Prilosec OTC is a Oral Tablet, Delayed Release in the Human Otc Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Omeprazole Magnesium.

Product ID70518-2167_8cc43dff-9cfb-6a35-e053-2995a90abe8f
NDC70518-2167
Product TypeHuman Otc Drug
Proprietary NamePrilosec OTC
Generic NameOmeprazole Magnesium
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2019-06-28
Marketing CategoryNDA / NDA
Application NumberNDA021229
Labeler NameREMEDYREPACK INC.
Substance NameOMEPRAZOLE MAGNESIUM
Active Ingredient Strength21 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-2167-0

30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-2167-0)
Marketing Start Date2019-06-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-2167-0 [70518216700]

Prilosec OTC TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA021229
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-06-28

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE MAGNESIUM20.6 mg/1

OpenFDA Data

SPL SET ID:677f8593-7488-4fd8-94e7-103c743b00ea
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 608796
  • 402014

    • NDC Crossover Matching brand name "Prilosec OTC" or generic name "Omeprazole Magnesium"

    NDCBrand NameGeneric Name
    37000-455Prilosec OTComeprazole magnesium
    37000-459Prilosec OTCOMEPRAZOLE MAGNESIUM
    70518-2167Prilosec OTCPrilosec OTC
    70000-0232Acid ReducerOmeprazole Magnesium
    0113-0045Good Sense omeprazoleOmeprazole magnesium
    0363-9980OmeprazoleOMEPRAZOLE MAGNESIUM
    11673-948OmeprazoleOmeprazole Magnesium
    59726-297OmeprazoleOmeprazole magnesium
    59726-737OmeprazoleOmeprazole magnesium
    0179-8104Omeprazole MagnesiumOmeprazole Magnesium
    0363-0042Omeprazole MagnesiumOmeprazole Magnesium
    21130-398Omeprazole MagnesiumOmeprazole Magnesium
    37808-006Omeprazole MagnesiumOmeprazole Magnesium
    37835-891Omeprazole MagnesiumOMEPRAZOLE MAGNESIUM
    41250-064Omeprazole MagnesiumOmeprazole Magnesium
    43598-813Omeprazole MagnesiumOmeprazole Magnesium
    53943-520Omeprazole MagnesiumOmeprazole Magnesium
    55111-397Omeprazole MagnesiumOmeprazole Magnesium
    55315-367Omeprazole MagnesiumOmeprazole Magnesium
    55315-368Omeprazole MagnesiumOmeprazole Magnesium
    55319-916Omeprazole MagnesiumOmeprazole Magnesium
    57896-759Omeprazole MagnesiumOmeprazole Magnesium
    63868-177Omeprazole MagnesiumOmeprazole Magnesium
    66993-426Omeprazole magnesiumomeprazole magnesium
    66993-427Omeprazole magnesiumomeprazole magnesium
    68016-760Omeprazole MagnesiumOmeprazole Magnesium
    69842-027Omeprazole MagnesiumOmeprazole Magnesium
    0186-0610PRILOSECOmeprazole magnesium
    0186-0625PRILOSECOmeprazole magnesium
    70515-610Prilosecomeprazole magnesium
    70515-625Prilosecomeprazole magnesium

    Trademark Results [Prilosec OTC]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PRILOSEC OTC
    PRILOSEC OTC
    78132922 2793047 Live/Registered
    AstraZeneca AB
    2002-06-03
    PRILOSEC OTC
    PRILOSEC OTC
    75555244 not registered Dead/Abandoned
    ASTRAZENECA AB
    1998-09-18
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