NDC 16729-252

Esomeprazole sodium

Esomeprazole Sodium

Esomeprazole sodium is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Accord Healthcare Inc.. The primary component is Esomeprazole Sodium.

Product ID16729-252_58f95c88-fece-9d32-e053-2991aa0a53b2
NDC16729-252
Product TypeHuman Prescription Drug
Proprietary NameEsomeprazole sodium
Generic NameEsomeprazole Sodium
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2016-10-11
Marketing CategoryANDA / ANDA
Application NumberANDA205379
Labeler NameAccord Healthcare Inc.
Substance NameESOMEPRAZOLE SODIUM
Active Ingredient Strength40 mg/5mL
Pharm ClassesProton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 16729-252-66

1 VIAL in 1 CARTON (16729-252-66) > 5 mL in 1 VIAL
Marketing Start Date2016-10-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16729-252-69 [16729025269]

Esomeprazole sodium INJECTION
Marketing CategoryANDA
Application NumberANDA205379
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-11

NDC 16729-252-66 [16729025266]

Esomeprazole sodium INJECTION
Marketing CategoryANDA
Application NumberANDA205379
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-11

Drug Details

Active Ingredients

IngredientStrength
ESOMEPRAZOLE SODIUM40 mg/5mL

OpenFDA Data

SPL SET ID:86d1239e-8c9f-4a6c-ab5a-ddecc91a1c4c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 486501
  • UPC Code
  • 0316729252669
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.