FDA.reportPublic FDA data

Omeprazole

Product NDC
68071-1943
11-digit product format
680711943
Labeler code
68071
Product ID
68071-1943_dec2cba8-3a84-6c79-e053-2a95a90aa088
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA078490
Marketing category
ANDA
Marketing start
2014-03-01
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
40 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
68071-1943-62025-01-30C16284748780-12cef2736-9a27-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
68071-1943-6Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-1943OMEPRAZOLE CAPSULE, DELAYED RELEASE [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20220512_dec2cba8-3a85-6c79-e053-2a95a90aa088.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSNdec2cba8-3a85-6c79-e053-2a95a90aa0881
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDdec2cba8-3a85-6c79-e053-2a95a90aa0881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-1943-66807119430660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-1943-6) 2022-05-110000-00-00NoNoCurrent