NDC 0186-6040

NEXIUM I.V.

Esomeprazole Sodium

NEXIUM I.V. is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Esomeprazole Sodium.

Product ID0186-6040_24d37125-c3cf-48e0-9e50-75cbc818e7c1
NDC0186-6040
Product TypeHuman Prescription Drug
Proprietary NameNEXIUM I.V.
Generic NameEsomeprazole Sodium
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2005-05-03
Marketing CategoryNDA / NDA
Application NumberNDA021689
Labeler NameAstraZeneca Pharmaceuticals LP
Substance NameESOMEPRAZOLE SODIUM
Active Ingredient Strength40 mg/5mL
Pharm ClassesCytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0186-6040-01

10 VIAL in 1 CARTON (0186-6040-01) > 5 mL in 1 VIAL
Marketing Start Date2005-05-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0186-6040-01 [00186604001]

NEXIUM I.V. INJECTION
Marketing CategoryNDA
Application NumberNDA021689
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-05-03

Drug Details

Active Ingredients

IngredientStrength
ESOMEPRAZOLE SODIUM40 mg/5mL

OpenFDA Data

SPL SET ID:c325bbfc-46f3-471e-7bbc-ed0d6965d13b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 486499
  • 486501
  • 603534
  • 603536
  • Pharmacological Class

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

    NDC Crossover Matching brand name "NEXIUM I.V." or generic name "Esomeprazole Sodium"

    NDCBrand NameGeneric Name
    14335-060Esomeprazole sodiumEsomeprazole sodium
    16729-252Esomeprazole sodiumEsomeprazole sodium
    17478-850Esomeprazole SodiumEsomeprazole Sodium
    55150-184Esomeprazole SodiumEsomeprazole Sodium
    55150-185Esomeprazole SodiumEsomeprazole Sodium
    62756-508Esomeprazole SodiumEsomeprazole Sodium
    62756-509Esomeprazole SodiumEsomeprazole Sodium
    67457-392Esomeprazole sodiumEsomeprazole sodium
    68083-451Esomeprazole SodiumEsomeprazole Sodium
    68083-452Esomeprazole SodiumEsomeprazole Sodium
    70436-190Esomeprazole sodiumEsomeprazole sodium
    0186-6020NEXIUMEsomeprazole sodium
    0186-6040NEXIUMEsomeprazole sodium

    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.