NDC 65162-955

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 Llc. The primary component is Esomeprazole Strontium.

Product ID65162-955_1bd5463a-ed4b-48ac-baab-3c5cf07465cb
NDC65162-955
Product TypeHuman Prescription Drug
Proprietary NameEsomeprazole strontium
Generic NameEsomeprazole Strontium
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2013-08-12
Marketing CategoryNDA AUTHORIZED GENERIC / NDA
Application NumberNDA202342
Labeler NameAmneal Pharmaceuticals LLC
Substance NameESOMEPRAZOLE STRONTIUM
Active Ingredient Strength20 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 65162-955-03

30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65162-955-03)
Marketing Start Date2013-08-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65162-955-03 [65162095503]

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

Drug Details

Active Ingredients

IngredientStrength
ESOMEPRAZOLE STRONTIUM20 mg/1

OpenFDA Data

SPL SET ID:61a5a84e-0194-4f11-91f8-83d7ac404932
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1810789
  • 1810787
  • UPC Code
  • 0365162957037
  • 0365162955033
  • Pharmacological Class

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

    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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