NDC 65862-783

Esomeprazole Magnesium

Esomeprazole Magnesium

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

Product ID65862-783_1a744005-3f34-483b-80a7-fdf38943f608
NDC65862-783
Product TypeHuman Prescription Drug
Proprietary NameEsomeprazole Magnesium
Generic NameEsomeprazole Magnesium
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2016-04-21
Marketing CategoryANDA / DRUG FOR FURTHER PROCESSING
Application NumberANDA205606
Labeler NameAurobindo Pharma Limited
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 65862-783-01

100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-783-01)
Marketing Start Date2016-04-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65862-783-10 [65862078310]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA205606
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-04-21

NDC 65862-783-90 [65862078390]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA205606
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-04-21

NDC 65862-783-78 [65862078378]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA205606
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-04-21

NDC 65862-783-99 [65862078399]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA205606
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-04-21

NDC 65862-783-30 [65862078330]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA205606
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-04-21

NDC 65862-783-01 [65862078301]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA205606
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-04-21

Drug Details

Active Ingredients

IngredientStrength
ESOMEPRAZOLE MAGNESIUM DIHYDRATE20 mg/1

Medicade Reported Pricing

65862078390 ESOMEPRAZOLE MAG DR 20 MG CAP

Pricing Unit: EA | Drug Type:

65862078330 ESOMEPRAZOLE MAG DR 20 MG CAP

Pricing Unit: EA | Drug Type:

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.