NDC 71335-0052

ESOMEPRAZOLE MAGNESIUM

Esomeprazole Magnesium

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

Product ID71335-0052_032eb912-21fa-4da2-8575-61cc08d907cb
NDC71335-0052
Product TypeHuman Prescription Drug
Proprietary NameESOMEPRAZOLE MAGNESIUM
Generic NameEsomeprazole Magnesium
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2015-10-19
Marketing CategoryANDA / ANDA
Application NumberANDA203636
Labeler NameBryant Ranch Prepack
Substance NameESOMEPRAZOLE MAGNESIUM
Active Ingredient Strength40 mg/1
Pharm ClassesCytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 71335-0052-1

90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0052-1)
Marketing Start Date2018-02-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0052-2 [71335005202]

ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203636
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-05-24

NDC 71335-0052-1 [71335005201]

ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203636
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-05-24

NDC 71335-0052-7 [71335005207]

ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203636
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-05-24

NDC 71335-0052-4 [71335005204]

ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203636
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-05-24

NDC 71335-0052-3 [71335005203]

ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203636
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-05-24

NDC 71335-0052-6 [71335005206]

ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203636
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-05-24

NDC 71335-0052-5 [71335005205]

ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203636
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-05-24

Drug Details

Active Ingredients

IngredientStrength
ESOMEPRAZOLE MAGNESIUM40 mg/1

OpenFDA Data

SPL SET ID:1724d214-0730-49e4-9e33-69f0497aad2a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 606730

    • Pharmacological Class

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