NDC 55150-185

Esomeprazole Sodium

Esomeprazole Sodium

Esomeprazole Sodium is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Auromedics Pharma Llc. The primary component is Esomeprazole Sodium.

Product ID55150-185_1cc540ab-a7ea-46f1-ab63-86f1251795ed
NDC55150-185
Product TypeHuman Prescription Drug
Proprietary NameEsomeprazole Sodium
Generic NameEsomeprazole Sodium
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2016-08-10
Marketing CategoryANDA / ANDA
Application NumberANDA204657
Labeler NameAuroMedics Pharma LLC
Substance NameESOMEPRAZOLE SODIUM
Active Ingredient Strength40 mg/1
Pharm ClassesCytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 55150-185-05

10 VIAL in 1 CARTON (55150-185-05) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
Marketing Start Date2016-08-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55150-185-05 [55150018505]

Esomeprazole Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA204657
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-08-10

Drug Details

Active Ingredients

IngredientStrength
ESOMEPRAZOLE SODIUM40 mg/1

OpenFDA Data

SPL SET ID:45a15ba2-2aae-4edc-beaa-4a2357d87f32
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 486499
  • 486501
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Esomeprazole Sodium" 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

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