FDA.reportPublic FDA data

Omeprazole

Product NDC
67046-519
11-digit product format
670460519
Labeler code
67046
Product ID
67046-519_598da612-ccb2-7c5d-e053-2a91aa0ae771
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA076048
Marketing category
ANDA
Marketing start
2017-09-19
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
No
Listing certified through
2020-12-31
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
67046-519-072022-01-28C16284748780-1d6a99b39-9c97-a426-e053-dadaa90af4c2These 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. OMEPRAZOLE delayed-release capsules, for oral use 519 Initial U.S. Approval: 1989
67046-519-142022-01-28C16284748780-1d6a99b39-9c97-a426-e053-dadaa90af4c2These 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. OMEPRAZOLE delayed-release capsules, for oral use 519 Initial U.S. Approval: 1989
67046-519-152022-01-28C16284748780-1d6a99b39-9c97-a426-e053-dadaa90af4c2These 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. OMEPRAZOLE delayed-release capsules, for oral use 519 Initial U.S. Approval: 1989
67046-519-212022-01-28C16284748780-1d6a99b39-9c97-a426-e053-dadaa90af4c2These 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. OMEPRAZOLE delayed-release capsules, for oral use 519 Initial U.S. Approval: 1989
67046-519-282022-01-28C16284748780-1d6a99b39-9c97-a426-e053-dadaa90af4c2These 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. OMEPRAZOLE delayed-release capsules, for oral use 519 Initial U.S. Approval: 1989
67046-519-302022-01-28C16284748780-1d6a99b39-9c97-a426-e053-dadaa90af4c2These 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. OMEPRAZOLE delayed-release capsules, for oral use 519 Initial U.S. Approval: 1989
67046-519-602022-01-28C16284748780-1d6a99b39-9c97-a426-e053-dadaa90af4c2These 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. OMEPRAZOLE delayed-release capsules, for oral use 519 Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-519-07Omeprazole7 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE71
67046-519-14Omeprazole14 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE141
67046-519-15Omeprazole15 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE151
67046-519-21Omeprazole21 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE211
67046-519-28Omeprazole28 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE281
67046-519-30Omeprazole30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE301
67046-519-60Omeprazole60 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-519OMEPRAZOLE CAPSULE, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 7 package rows20170919_598da612-ccb1-7c5d-e053-2a91aa0ae771.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN598da612-ccb1-7c5d-e053-2a91aa0ae7711
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD598da612-ccb1-7c5d-e053-2a91aa0ae7711
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY598da612-ccb1-7c5d-e053-2a91aa0ae7711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67046-519-07670460519077 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (67046-519-07) 2017-09-190000-00-00NoNoCurrent
67046-519-146704605191414 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (67046-519-14) 2017-09-190000-00-00NoNoCurrent
67046-519-156704605191515 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (67046-519-15) 2017-09-190000-00-00NoNoCurrent
67046-519-216704605192121 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (67046-519-21) 2017-09-190000-00-00NoNoCurrent
67046-519-286704605192828 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (67046-519-28) 2017-09-190000-00-00NoNoCurrent
67046-519-306704605193030 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (67046-519-30) 2017-09-190000-00-00NoNoCurrent
67046-519-606704605196060 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (67046-519-60) 2017-09-190000-00-00NoNoCurrent