NDC 70849-200

ESOMEPRAZOLE STRONTIUM

Esomeprazole Strontium

ESOMEPRAZOLE STRONTIUM is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by R2 Pharma, Llc. The primary component is Esomeprazole Strontium.

Product ID70849-200_3d19523d-7cb5-2f2f-e054-00144ff88e88
NDC70849-200
Product TypeHuman Prescription Drug
Proprietary NameESOMEPRAZOLE STRONTIUM
Generic NameEsomeprazole Strontium
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2016-09-15
Marketing CategoryNDA / NDA
Application NumberNDA202342
Labeler NameR2 Pharma, 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 70849-200-30

30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70849-200-30)
Marketing Start Date2016-09-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70849-200-30 [70849020030]

ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA202342
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-09-15

Drug Details

Active Ingredients

IngredientStrength
ESOMEPRAZOLE STRONTIUM20 mg/1

OpenFDA Data

SPL SET ID:3c916d32-f9e9-1d15-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1810789
  • 1810787
  • UPC Code
  • 0370849400300
  • 0370849200306
  • Pharmacological Class

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