NDC 45865-892

Esomeprazole Magnesium

Esomeprazole Magnesium

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

Product ID45865-892_7df002ca-e0b0-24fe-e053-2991aa0ab75f
NDC45865-892
Product TypeHuman Prescription Drug
Proprietary NameEsomeprazole Magnesium
Generic NameEsomeprazole Magnesium
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2016-04-21
Marketing CategoryANDA / ANDA
Application NumberANDA205606
Labeler Namemedsourcer pharmaceuticals
Substance NameESOMEPRAZOLE MAGNESIUM DIHYDRATE
Active Ingredient Strength20 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 45865-892-30

30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45865-892-30)
Marketing Start Date2018-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45865-892-60 [45865089260]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA205606
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-01

NDC 45865-892-30 [45865089230]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA205606
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-01

Drug Details

Active Ingredients

IngredientStrength
ESOMEPRAZOLE MAGNESIUM DIHYDRATE20 mg/1

OpenFDA Data

SPL SET ID:7df009b0-311a-3d49-e053-2991aa0a3c44
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 606726
  • 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

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