NDC 61919-789

ESOMEPRAZOLE MAGNESIUM DR

Esomeprazole Magnesium

ESOMEPRAZOLE MAGNESIUM DR is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Directrx. The primary component is Esomeprazole Magnesium.

Product ID61919-789_8504300f-a585-29ed-e053-2a91aa0ad26c
NDC61919-789
Product TypeHuman Prescription Drug
Proprietary NameESOMEPRAZOLE MAGNESIUM DR
Generic NameEsomeprazole Magnesium
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2019-03-26
Marketing CategoryANDA / ANDA
Application NumberANDA208333
Labeler NameDirectRX
Substance NameESOMEPRAZOLE MAGNESIUM
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 61919-789-30

30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (61919-789-30)
Marketing Start Date2019-03-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-789-30 [61919078930]

ESOMEPRAZOLE MAGNESIUM DR CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA208333
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-26

NDC 61919-789-60 [61919078960]

ESOMEPRAZOLE MAGNESIUM DR CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA208333
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-26

Drug Details

Active Ingredients

IngredientStrength
ESOMEPRAZOLE MAGNESIUM20 mg/1

OpenFDA Data

SPL SET ID:8504300f-a584-29ed-e053-2a91aa0ad26c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 606726
  • Pharmacological Class

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

    NDC Crossover Matching brand name "ESOMEPRAZOLE MAGNESIUM DR" or generic name "Esomeprazole Magnesium"

    NDCBrand NameGeneric Name
    61919-789ESOMEPRAZOLE MAGNESIUM DRESOMEPRAZOLE MAGNESIUM DR
    0093-6450Esomeprazole MagnesiumEsomeprazole Magnesium
    0093-6451Esomeprazole MagnesiumEsomeprazole Magnesium
    0186-0382Esomeprazole magnesiumEsomeprazole magnesium
    0186-0384Esomeprazole magnesiumEsomeprazole magnesium
    0186-4010NEXIUMEsomeprazole magnesium
    0186-4020NEXIUMEsomeprazole magnesium
    0186-4025NEXIUMEsomeprazole magnesium

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