Esomeprazole Magnesium

Product NDC
68788-8131
11-digit product format
687888131
Labeler code
68788
Product ID
68788-8131_40182782-cc3a-467d-bb13-f7b9d736b47d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA211977
Marketing category
ANDA
Marketing start
2022-02-04
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8131-1EA - Each68788-81310035b5af-3a1e-42fe-9d95-d6afbe84d81a12022-03-09
68788-8131-2EA - Each68788-81314475cc14-ec45-4cc4-9895-dbeaf658a80512022-03-09
68788-8131-3EA - Each68788-8131668362e2-0a13-4d7f-bb21-6b84b5cf746012022-03-09
68788-8131-6EA - Each68788-8131aec18bf7-1a14-48a0-8fe7-60b341e10c5212022-03-09
68788-8131-9EA - Each68788-8131d2fe852c-d9e0-48bb-97f4-625168f68dc512022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8131ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]4Legacy NDC20250412_40182782-cc3a-467d-bb13-f7b9d736b47d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8131-168788813101100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8131-1) 2022-02-040000-00-00NoNoCurrent
68788-8131-26878881310220 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8131-2) 2022-02-040000-00-00NoNoCurrent
68788-8131-36878881310330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8131-3) 2022-02-040000-00-00NoNoCurrent
68788-8131-66878881310660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8131-6) 2022-02-040000-00-00NoNoCurrent
68788-8131-96878881310990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8131-9) 2022-02-040000-00-00NoNoCurrent