Esomeprazole magnesium

Product NDC
68071-2241
11-digit product format
680712241
Labeler code
68071
Product ID
68071-2241_d7754d2b-da30-34c2-e053-2a95a90ab923
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
Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2241-42022-02-09C16284748780-1d6a99b39-c6fb-a426-e053-dadaa90af4c2ad2be25f-7dd1-83ea-e053-2995a90adea1
68071-2241-42022-01-28C16284748780-1d6a99b39-c6fb-a426-e053-dadaa90af4c2ad2be25f-7dd1-83ea-e053-2995a90adea1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2241-46807122410414 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2241-4) 2020-08-180000-00-00NoNoCurrent