FDA.reportPublic FDA data

Omeprazole

Product NDC
68071-2655
11-digit product format
680712655
Labeler code
68071
Product ID
68071-2655_da481c98-3cfe-1c05-e053-2995a90a8a35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA075757
Marketing category
ANDA
Marketing start
2019-07-01
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2655-12025-01-30C16284748780-12cef2736-a3ea-d83d-e063-dadaa90ab31fThese 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 Initial U.S. Approval: 1989
68071-2655-22025-01-30C16284748780-12cef2736-a3ea-d83d-e063-dadaa90ab31fThese 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 Initial U.S. Approval: 1989
68071-2655-32025-01-30C16284748780-12cef2736-a3ea-d83d-e063-dadaa90ab31fThese 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 Initial U.S. Approval: 1989
68071-2655-42025-01-30C16284748780-12cef2736-a3ea-d83d-e063-dadaa90ab31fThese 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 Initial U.S. Approval: 1989
68071-2655-62025-01-30C16284748780-12cef2736-a3ea-d83d-e063-dadaa90ab31fThese 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 Initial U.S. Approval: 1989
68071-2655-72025-01-30C16284748780-12cef2736-a3ea-d83d-e063-dadaa90ab31fThese 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 Initial U.S. Approval: 1989
68071-2655-82025-01-30C16284748780-12cef2736-a3ea-d83d-e063-dadaa90ab31fThese 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 Initial U.S. Approval: 1989
68071-2655-92025-01-30C16284748780-12cef2736-a3ea-d83d-e063-dadaa90ab31fThese 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 Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2655-1Omeprazole15 in 1 BOTTLECAPSULE, DELAYED RELEASE152
68071-2655-2Omeprazole20 in 1 BOTTLECAPSULE, DELAYED RELEASE202
68071-2655-3Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE302
68071-2655-4Omeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
68071-2655-6Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE602
68071-2655-7Omeprazole7 in 1 BOTTLECAPSULE, DELAYED RELEASE72
68071-2655-8Omeprazole180 in 1 BOTTLECAPSULE, DELAYED RELEASE1802
68071-2655-9Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2655OMEPRAZOLE CAPSULE, DELAYED RELEASE [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 8 package rows20230418_da481f9e-dfa8-3682-e053-2a95a90a333c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNda481f9e-dfa8-3682-e053-2a95a90a333c2
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDda481f9e-dfa8-3682-e053-2a95a90a333c2
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYda481f9e-dfa8-3682-e053-2a95a90a333c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2655-16807126550115 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2655-1) 2022-03-150000-00-00NoNoCurrent
68071-2655-26807126550220 in 1 BOTTLEHistorical
68071-2655-36807126550330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2655-3) 2022-03-150000-00-00NoNoCurrent
68071-2655-46807126550414 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2655-4) 2022-03-150000-00-00NoNoCurrent
68071-2655-66807126550660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2655-6) 2022-03-150000-00-00NoNoCurrent
68071-2655-7680712655077 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2655-7) 2022-03-150000-00-00NoNoCurrent
68071-2655-868071265508180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2655-8) 2022-03-150000-00-00NoNoCurrent
68071-2655-96807126550990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2655-9) 2022-03-150000-00-00NoNoCurrent