Omeprazole

Product NDC
67296-1615
11-digit product format
672961615
Labeler code
67296
Product ID
67296-1615_d61c347b-4222-e018-e053-2995a90a4f4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA091672
Marketing category
ANDA
Marketing start
2018-01-01
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
20 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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1615-32024-01-30C16284748780-11030e365-3ea0-111a-e063-dadaa90a10e2omep

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1615-3Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1615OMEPRAZOLE CAPSULE, DELAYED RELEASE [REDPHARM DRUG, INC.]3Legacy NDC, 1 package rows20220122_6cceb8a3-d35a-f3e0-e053-2991aa0a6360.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN6cceb8a3-d35a-f3e0-e053-2991aa0a63603
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD6cceb8a3-d35a-f3e0-e053-2991aa0a63603
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY6cceb8a3-d35a-f3e0-e053-2991aa0a63603

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1615-36729616150330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67296-1615-3) 2018-01-010000-00-00NoNoCurrent