NDC 0904-6580

Esomeprazole Magnesium

Esomeprazole Magnesium

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

Product ID0904-6580_efe891ab-d211-4d46-900a-109550bd9925
NDC0904-6580
Product TypeHuman Prescription Drug
Proprietary NameEsomeprazole Magnesium
Generic NameEsomeprazole Magnesium
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2015-12-10
Marketing CategoryANDA / ANDA
Application NumberANDA078279
Labeler NameMajor Pharmaceuticals
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 Through2019-12-31

Packaging

NDC 0904-6580-61

100 BLISTER PACK in 1 CARTON (0904-6580-61) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
Marketing Start Date2015-12-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6580-61 [00904658061]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA078279
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-10
Marketing End Date2015-12-10

Drug Details

Active Ingredients

IngredientStrength
ESOMEPRAZOLE MAGNESIUM20 mg/1

OpenFDA Data

SPL SET ID:ba65c73d-fc7d-491e-aaaa-cf45a7783395
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 606730
  • 606726
  • 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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