FDA.reportPublic FDA data

Omeprazole

Product NDC
67046-520
11-digit product format
670460520
Labeler code
67046
Product ID
67046-520_ab5f9512-335f-4490-a6a9-12f611646991
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA075410
Marketing category
ANDA
Marketing start
2010-03-09
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
20 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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
67046-520-302019-10-21C16284748780-1956f9ecf-bf0a-621f-e053-dbdaa90a74adThese highlights do not include all the information needed to use Omeprazole Delayed-Release Capsules safely and effectively. See full prescribing information for Omeprazole Delayed-Release Capsules. Initial U.S. Approval: 2002
67046-520-602019-10-21C16284748780-1956f9ecf-bf0a-621f-e053-dbdaa90a74adThese highlights do not include all the information needed to use Omeprazole Delayed-Release Capsules safely and effectively. See full prescribing information for Omeprazole Delayed-Release Capsules. Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-520-30Omeprazole30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE PELLETS301
67046-520-60Omeprazole60 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE PELLETS601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-520OMEPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 2 package rows20100310_ab5f9512-335f-4490-a6a9-12f611646991.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNab5f9512-335f-4490-a6a9-12f6116469911
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDab5f9512-335f-4490-a6a9-12f6116469911
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYab5f9512-335f-4490-a6a9-12f6116469911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-520-306704605203030 in 1 BLISTER PACKHistorical
67046-520-606704605206060 in 1 BLISTER PACKHistorical