NDC 42292-010

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 Institutional Inc.. The primary component is Esomeprazole Magnesium.

Product ID42292-010_7cd85a83-2de1-16cd-e053-2a91aa0a6930
NDC42292-010
Product TypeHuman Prescription Drug
Proprietary NameEsomeprazole Magnesium
Generic NameEsomeprazole Magnesium
Dosage FormCapsule, Delayed Release Pellets
Route of AdministrationORAL
Marketing Start Date2016-05-31
Marketing CategoryANDA / ANDA
Application NumberANDA078936
Labeler NameMylan Institutional 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 Through2019-12-31

Packaging

NDC 42292-010-16

60 BLISTER PACK in 1 CARTON (42292-010-16) > 1 CAPSULE, DELAYED RELEASE PELLETS in 1 BLISTER PACK (42292-010-01)
Marketing Start Date2016-05-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42292-010-20 [42292001020]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA078936
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-31
Marketing End Date2017-12-11

NDC 42292-010-16 [42292001016]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA078936
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-31

NDC 42292-010-01 [42292001001]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA078936
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-31

Drug Details

Active Ingredients

IngredientStrength
ESOMEPRAZOLE MAGNESIUM40 mg/1

OpenFDA Data

SPL SET ID:4332634f-fde0-4b98-8735-d3ab865189c3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 606730
  • 606726
  • Pharmacological Class

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

    Medicade Reported Pricing

    42292001016 ESOMEPRAZOLE MAG DR 40 MG CAP

    Pricing Unit: EA | Drug Type:

    42292001001 ESOMEPRAZOLE MAG DR 40 MG CAP

    Pricing Unit: EA | Drug Type:

    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.