Esomeprazole magnesium

Product NDC
68071-5270
11-digit product format
680715270
Labeler code
68071
Product ID
68071-5270_a7464b24-e0a2-b466-e053-2995a90a997e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA209735
Marketing category
ANDA
Marketing start
2018-05-31
Marketing end
0000-00-00
Substance
ESOMEPRAZOLE MAGNESIUM
Active strength
40 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5270-92024-08-19C16284748780-1d6a99b39-3fc6-a426-e053-dadaa90af4c2a7464317-9517-84d7-e053-2995a90af2b1
68071-5270-92022-01-28C16284748780-1d6a99b39-3fc6-a426-e053-dadaa90af4c2a7464317-9517-84d7-e053-2995a90af2b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-5270-96807152700990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-5270-9) 2020-06-040000-00-00NoNoCurrent