NDC 62756-509

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 Sun Pharmaceutical Industries Limited. The primary component is Esomeprazole Sodium.

Product ID62756-509_c1aee218-5681-4f2e-9fd5-c356b0f81e41
NDC62756-509
Product TypeHuman Prescription Drug
Proprietary NameEsomeprazole Sodium
Generic NameEsomeprazole Sodium
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2014-12-15
Marketing CategoryANDA / ANDA
Application NumberANDA200882
Labeler NameSun Pharmaceutical Industries Limited
Substance NameESOMEPRAZOLE SODIUM
Active Ingredient Strength40 mg/5mL
Pharm ClassesProton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 62756-509-44

10 VIAL, SINGLE-USE in 1 CARTON (62756-509-44) > 5 mL in 1 VIAL, SINGLE-USE (62756-509-40)
Marketing Start Date2014-12-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62756-509-44 [62756050944]

Esomeprazole Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA200882
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-12-15
Marketing End Date2016-07-31

NDC 62756-509-40 [62756050940]

Esomeprazole Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA200882
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-12-15
Marketing End Date2016-07-31

Drug Details

Active Ingredients

IngredientStrength
ESOMEPRAZOLE SODIUM40 mg/5mL

OpenFDA Data

SPL SET ID:6522751a-b188-4117-b6b9-5b2d120f2c83
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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