NDC 68382-442

esomeprazole magnesium

Esomeprazole Magnesium

esomeprazole magnesium is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Esomeprazole Magnesium Dihydrate.

Product ID68382-442_73ee6f58-3c80-4bb1-8757-1ecddb8868fe
NDC68382-442
Product TypeHuman Prescription Drug
Proprietary Nameesomeprazole magnesium
Generic NameEsomeprazole Magnesium
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2019-05-30
Marketing CategoryANDA / ANDA
Application NumberANDA206296
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameESOMEPRAZOLE MAGNESIUM DIHYDRATE
Active Ingredient Strength40 mg/1
Pharm ClassesProton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 68382-442-06

30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-442-06)
Marketing Start Date2019-05-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-442-16 [68382044216]

esomeprazole magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA206296
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-30

NDC 68382-442-06 [68382044206]

esomeprazole magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA206296
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-30

NDC 68382-442-10 [68382044210]

esomeprazole magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA206296
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-30

Drug Details

Active Ingredients

IngredientStrength
ESOMEPRAZOLE MAGNESIUM DIHYDRATE40 mg/1

OpenFDA Data

SPL SET ID:c4b0571e-7b09-441b-90be-bc653806812b
Manufacturer
UNII

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
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