FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
68071-4457
11-digit product format
680714457
Labeler code
68071
Product ID
68071-4457_6d82518b-db04-d57e-e053-2991aa0a71b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA205606
Marketing category
ANDA
Marketing start
2016-04-21
Marketing end
0000-00-00
Substance
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
Active strength
20 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4457-12020-06-15C16284748780-19d75b9cf-fa73-f424-e053-dadaa90a57ce6d81d9e3-23cd-1e9c-e053-2991aa0a17d1
68071-4457-62020-06-15C16284748780-19d75b9cf-fa73-f424-e053-dadaa90a57ce6d81d9e3-23cd-1e9c-e053-2991aa0a17d1
68071-4457-12020-01-31C16284748780-19d75b9cf-fa73-f424-e053-dadaa90a57ce6d81d9e3-23cd-1e9c-e053-2991aa0a17d1
68071-4457-62020-01-31C16284748780-19d75b9cf-fa73-f424-e053-dadaa90a57ce6d81d9e3-23cd-1e9c-e053-2991aa0a17d1