NDC 68083-451

Esomeprazole Sodium

Esomeprazole Sodium

Esomeprazole Sodium is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Esomeprazole Sodium.

Product ID68083-451_587c4f14-9800-4d26-9bc7-51a1abebaa5d
NDC68083-451
Product TypeHuman Prescription Drug
Proprietary NameEsomeprazole Sodium
Generic NameEsomeprazole Sodium
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-04-01
Marketing CategoryANDA / ANDA
Application NumberANDA203349
Labeler NameGland Pharma Limited
Substance NameESOMEPRAZOLE SODIUM
Active Ingredient Strength20 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 68083-451-10

10 VIAL in 1 CARTON (68083-451-10) > 5 mL in 1 VIAL (68083-451-01)
Marketing Start Date2020-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68083-451-01 [68083045101]

Esomeprazole Sodium INJECTION
Marketing CategoryANDA
Application NumberANDA203349
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-01

NDC 68083-451-10 [68083045110]

Esomeprazole Sodium INJECTION
Marketing CategoryANDA
Application NumberANDA203349
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-01

Drug Details

Active Ingredients

IngredientStrength
ESOMEPRAZOLE SODIUM20 mg/5mL

OpenFDA Data

SPL SET ID:9354958c-e997-41c8-8605-23f0a58993c0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 486499
  • 486501
  • UPC Code
  • 0368083452100
  • 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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