NDC 53746-957

Esomeprazole strontium

Esomeprazole Strontium

Esomeprazole strontium is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Of New York Llc. The primary component is Esomeprazole Strontium.

Product ID53746-957_51fcd43d-087b-4590-9724-6e5e339ab286
NDC53746-957
Product TypeHuman Prescription Drug
Proprietary NameEsomeprazole strontium
Generic NameEsomeprazole Strontium
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2013-08-12
Marketing CategoryNDA / NDA
Application NumberNDA202342
Labeler NameAmneal Pharmaceuticals of New York LLC
Substance NameESOMEPRAZOLE STRONTIUM
Active Ingredient Strength40 mg/1
Pharm ClassesProton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 53746-957-03

30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (53746-957-03)
Marketing Start Date2013-08-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53746-957-03 [53746095703]

Esomeprazole strontium CAPSULE, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA202342
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-08-12

Drug Details

Active Ingredients

IngredientStrength
ESOMEPRAZOLE STRONTIUM40 mg/1

OpenFDA Data

SPL SET ID:e2e18e10-6f02-4ccc-842d-1962a3838b74
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1810789
  • 1810787
  • UPC Code
  • 0353746955036
  • 0353746957030
  • Pharmacological Class

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

    Medicade Reported Pricing

    53746095703 ESOMEPRAZOLE DR 49.3 MG CAP

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Esomeprazole strontium" or generic name "Esomeprazole Strontium"

    NDCBrand NameGeneric Name
    52246-400ESOMEPRAZOLE STRONTIUMesomeprazole strontium
    53746-955Esomeprazole strontiumEsomeprazole strontium
    53746-957Esomeprazole strontiumEsomeprazole strontium
    65162-955Esomeprazole strontiumEsomeprazole strontium
    65162-957Esomeprazole strontiumEsomeprazole strontium
    69336-129Esomeprazole strontiumEsomeprazole strontium
    70849-200ESOMEPRAZOLE STRONTIUMesomeprazole strontium
    70849-400ESOMEPRAZOLE STRONTIUMesomeprazole strontium

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