NDC 71335-0987

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 ID71335-0987_1f6398ae-c749-43df-925a-eaaf935f1bc0
NDC71335-0987
Product TypeHuman Prescription Drug
Proprietary NameEsomeprazole magnesium
Generic NameEsomeprazole Magnesium
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2017-10-20
Marketing CategoryANDA / ANDA
Application NumberANDA208333
Labeler NameBryant Ranch Prepack
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 Through2020-12-31

Packaging

NDC 71335-0987-1

90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0987-1)
Marketing Start Date2018-11-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0987-3 [71335098703]

Esomeprazole magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA208333
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-01
Marketing End Date2020-01-31

NDC 71335-0987-1 [71335098701]

Esomeprazole magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA208333
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-01
Marketing End Date2020-01-31

NDC 71335-0987-5 [71335098705]

Esomeprazole magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA208333
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-01
Marketing End Date2020-01-31

NDC 71335-0987-6 [71335098706]

Esomeprazole magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA208333
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-01
Marketing End Date2020-01-31

NDC 71335-0987-4 [71335098704]

Esomeprazole magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA208333
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-01
Marketing End Date2020-01-31

NDC 71335-0987-2 [71335098702]

Esomeprazole magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA208333
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-01
Marketing End Date2020-01-31

NDC 71335-0987-7 [71335098707]

Esomeprazole magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA208333
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-01
Marketing End Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ESOMEPRAZOLE MAGNESIUM40 mg/1

OpenFDA Data

SPL SET ID:86de48e4-da8c-4d13-87f4-1fa15c4edc2c
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
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