NDC 0378-2351

Esomeprazole Magnesium

Esomeprazole Magnesium

Esomeprazole Magnesium is a Oral Capsule, Delayed Release Pellets in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Esomeprazole Magnesium.

Product ID0378-2351_5387925b-75d6-44a9-bc5c-85a6c0a4bca1
NDC0378-2351
Product TypeHuman Prescription Drug
Proprietary NameEsomeprazole Magnesium
Generic NameEsomeprazole Magnesium
Dosage FormCapsule, Delayed Release Pellets
Route of AdministrationORAL
Marketing Start Date2015-08-03
Marketing CategoryANDA / ANDA
Application NumberANDA078936
Labeler NameMylan Pharmaceuticals Inc.
Substance NameESOMEPRAZOLE MAGNESIUM
Active Ingredient Strength40 mg/1
Pharm ClassesProton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0378-2351-77

90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2351-77)
Marketing Start Date2015-12-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-2351-10 [00378235110]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA078936
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-08-03
Marketing End Date2017-02-28

NDC 0378-2351-77 [00378235177]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA078936
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-07

NDC 0378-2351-93 [00378235193]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA078936
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-08-03

Drug Details

Active Ingredients

IngredientStrength
ESOMEPRAZOLE MAGNESIUM40 mg/1

OpenFDA Data

SPL SET ID:e04e7c84-59c8-4a1d-8dfc-d72588b97b59
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 606730
  • 606726
  • UPC Code
  • 0303782351934
  • 0303782350937
  • 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 Magnesium" or generic name "Esomeprazole Magnesium"

    NDCBrand NameGeneric Name
    0093-6450Esomeprazole MagnesiumEsomeprazole Magnesium
    0093-6451Esomeprazole MagnesiumEsomeprazole Magnesium
    0186-0382Esomeprazole magnesiumEsomeprazole magnesium
    0186-0384Esomeprazole magnesiumEsomeprazole magnesium
    67877-479Esomeprazole magnesiumEsomeprazole magnesium
    67877-478Esomeprazole magnesiumEsomeprazole magnesium
    68016-007Esomeprazole MagnesiumEsomeprazole Magnesium
    68071-3179ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUM
    68071-4213ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUM
    68071-4212Esomeprazole MagnesiumEsomeprazole Magnesium
    68071-4457Esomeprazole MagnesiumEsomeprazole Magnesium
    68071-4536Esomeprazole MagnesiumEsomeprazole Magnesium
    68071-4825Esomeprazole MagnesiumEsomeprazole Magnesium
    68196-977Esomeprazole MagnesiumEsomeprazole Magnesium
    68788-7201Esomeprazole MagnesiumEsomeprazole Magnesium
    68788-6922ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUM
    69842-898esomeprazole magnesiumesomeprazole magnesium
    69842-277Esomeprazole MagnesiumEsomeprazole Magnesium
    70518-0044ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUM
    70677-0069Esomeprazole MagnesiumEsomeprazole Magnesium
    71335-0987Esomeprazole magnesiumEsomeprazole magnesium
    71335-0709Esomeprazole MagnesiumEsomeprazole Magnesium
    71335-0807Esomeprazole MagnesiumEsomeprazole Magnesium
    71335-0052ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUM
    72036-800Esomeprazole MagnesiumEsomeprazole Magnesium
    0904-6581Esomeprazole MagnesiumEsomeprazole Magnesium
    0904-6580Esomeprazole MagnesiumEsomeprazole Magnesium
    11822-0898esomeprazole magnesiumesomeprazole magnesium
    13668-154ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUM
    13668-155ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUM
    16714-735Esomeprazole MagnesiumEsomeprazole Magnesium
    16714-736Esomeprazole MagnesiumEsomeprazole Magnesium
    30142-413esomeprazole magnesiumesomeprazole magnesium
    31722-573Esomeprazole MagnesiumEsomeprazole Magnesium
    31722-572Esomeprazole MagnesiumEsomeprazole Magnesium
    30142-261Esomeprazole MagnesiumEsomeprazole Magnesium
    37012-898esomeprazole magnesiumesomeprazole magnesium
    37808-898esomeprazole magnesiumesomeprazole magnesium
    37808-115Esomeprazole MagnesiumEsomeprazole Magnesium
    41250-900esomeprazole magnesiumesomeprazole magnesium
    42292-010Esomeprazole MagnesiumEsomeprazole Magnesium
    42292-009Esomeprazole MagnesiumEsomeprazole Magnesium
    42708-024Esomeprazole MagnesiumEsomeprazole Magnesium
    43598-407Esomeprazole MagnesiumEsomeprazole Magnesium
    43598-812Esomeprazole MagnesiumEsomeprazole Magnesium
    43598-509Esomeprazole MagnesiumEsomeprazole Magnesium
    43598-510Esomeprazole MagnesiumEsomeprazole Magnesium
    46122-538Esomeprazole MagnesiumEsomeprazole Magnesium
    45865-892Esomeprazole MagnesiumEsomeprazole Magnesium
    48792-7843esomeprazole magnesiumesomeprazole magnesium

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