NDC 0186-4010

NEXIUM

Esomeprazole Magnesium

NEXIUM is a Oral Granule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Esomeprazole Magnesium.

Product ID0186-4010_174c0650-2cad-48f9-9d07-4380ece09c8f
NDC0186-4010
Product TypeHuman Prescription Drug
Proprietary NameNEXIUM
Generic NameEsomeprazole Magnesium
Dosage FormGranule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2008-07-07
Marketing CategoryNDA / NDA
Application NumberNDA022101
Labeler NameAstraZeneca Pharmaceuticals LP
Substance NameESOMEPRAZOLE MAGNESIUM
Active Ingredient Strength10 mg/1
Pharm ClassesProton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0186-4010-01

30 GRANULE, DELAYED RELEASE in 1 CARTON (0186-4010-01)
Marketing Start Date2008-07-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0186-4010-01 [00186401001]

NEXIUM GRANULE, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA022101
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-07-07

NDC 0186-4010-02 [00186401002]

NEXIUM GRANULE, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA022101
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-07-07

Drug Details

Active Ingredients

IngredientStrength
ESOMEPRAZOLE MAGNESIUM10 mg/1

OpenFDA Data

SPL SET ID:f4853677-1622-4037-688b-fdf533a11d96
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861568
  • 1297658
  • 861570
  • 1297761
  • 861576
  • 1297763
  • 606730
  • 606726
  • 692578
  • 692576
  • 861583
  • 606728
  • 1297660
  • 606731

    • Pharmacological Class

    • Proton Pump Inhibitor [EPC]
    • Proton Pump Inhibitors [MoA]
    • Cytochrome P450 2C19 Inhibitors [MoA]
    • 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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.