NDC 55700-046

NEXIUM

Esomeprazole Magnesium

NEXIUM is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Esomeprazole Magnesium.

Product ID55700-046_1fc41617-435f-43d2-904e-44261f430832
NDC55700-046
Product TypeHuman Prescription Drug
Proprietary NameNEXIUM
Generic NameEsomeprazole Magnesium
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2013-11-15
Marketing CategoryNDA / NDA
Application NumberNDA021153
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameESOMEPRAZOLE MAGNESIUM
Active Ingredient Strength20 mg/1
Pharm ClassesProton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55700-046-30

30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-046-30)
Marketing Start Date2013-11-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55700-046-30 [55700004630]

NEXIUM CAPSULE, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA021153
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-11-15
Marketing End Date2019-10-11

Drug Details

Active Ingredients

IngredientStrength
ESOMEPRAZOLE MAGNESIUM20 mg/1

OpenFDA Data

SPL SET ID:a7d6cbf3-0fe7-4aad-9a9e-630c45ca9c39
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 606728
  • 606726
  • Pharmacological Class

    • Proton Pump Inhibitor [EPC]
    • Proton Pump Inhibitors [MoA]
    • Cytochrome P450 2C19 Inhibitors [MoA]

    NDC Crossover Matching brand name "NEXIUM" or generic name "Esomeprazole Magnesium"

    NDCBrand NameGeneric Name
    0186-4010NEXIUMEsomeprazole magnesium
    0186-4020NEXIUMEsomeprazole magnesium
    0186-4025NEXIUMEsomeprazole magnesium
    21695-092NEXIUMNEXIUM
    21695-091NEXIUMNEXIUM
    0186-4040NEXIUMNEXIUM
    0186-5040NEXIUMNEXIUM
    0186-5020NEXIUMNEXIUM
    0186-4050NEXIUMNEXIUM
    50090-0742NEXIUMNEXIUM
    49999-307NEXIUMNEXIUM
    50436-3121NEXIUMNEXIUM
    55154-9616NEXIUMNEXIUM
    55700-046NEXIUMNEXIUM
    61919-509NEXIUMNEXIUM
    63629-3311NEXIUMNEXIUM
    70518-2038NEXIUMNEXIUM
    80425-0111NexiumNexium
    0093-6450Esomeprazole MagnesiumEsomeprazole Magnesium
    0093-6451Esomeprazole MagnesiumEsomeprazole Magnesium
    0186-0382Esomeprazole magnesiumEsomeprazole magnesium
    0186-0384Esomeprazole magnesiumEsomeprazole magnesium

    Trademark Results [NEXIUM]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NEXIUM
    NEXIUM
    76155804 not registered Dead/Abandoned
    Bimini Bay Outfitters, Ltd.
    2000-10-27
    NEXIUM
    NEXIUM
    75646020 2483060 Live/Registered
    ASTRA AKTIEBOLAG
    1999-02-22
    NEXIUM
    NEXIUM
    74309333 1807883 Dead/Cancelled
    RICHARDS, CHRISTOS
    1992-08-31

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.