Omeprazole

Product NDC
68071-2442
11-digit product format
680712442
Labeler code
68071
Product ID
68071-2442_c4438015-efa0-6b6f-e053-2995a90a8c9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA091672
Marketing category
ANDA
Marketing start
2014-10-31
Marketing end
0000-00-00
Substance
OMEPRAZOLE
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2442-32023-01-30C16284748780-1f386c649-a3a1-0266-e053-dadaa90a7c1ac4438015-ef9f-6b6f-e053-2995a90a8c9b

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2442OMEPRAZOLE CAPSULE, DELAYED RELEASE [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC20210609_c4438015-ef9f-6b6f-e053-2995a90a8c9b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2442-36807124420330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2442-3) 2021-06-080000-00-00NoNoCurrent