NDC 61919-509

NEXIUM

Esomeprazole Magnesium

NEXIUM is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Esomeprazole Ma.

Product ID61919-509_3fa00edd-12ba-516d-e054-00144ff8d46c
NDC61919-509
Product TypeHuman Prescription Drug
Proprietary NameNEXIUM
Generic NameEsomeprazole Magnesium
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2014-01-01
Marketing CategoryANDA / NDA
Application NumberANDA021957
Labeler NameDIRECT RX
Substance NameESOMEPRAZOLE MA
Active Ingredient Strength40 mg/1
Pharm ClassesProton Pump Inh
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-509-30

30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (61919-509-30)
Marketing Start Date2014-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-509-60 [61919050960]

NEXIUM CAPSULE, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA021153
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-01-01

NDC 61919-509-30 [61919050930]

NEXIUM CAPSULE, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA021153
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-01

Drug Details

Active Ingredients

IngredientStrength
ESOMEPRAZOLE MAGNESIUM40 mg/1

OpenFDA Data

SPL SET ID:adaf210b-9a04-42f0-8887-2e1252efd1e2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 606730
  • 606731

    • 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.