FDA.reportPublic FDA data

OMEPRAZOLE

Product NDC
71610-326
11-digit product format
716100326
Labeler code
71610
Product ID
71610-326_dd92d39f-3922-4b3e-8b7d-c5b8727afafa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OMEPRAZOLE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA203481
Marketing category
ANDA
Marketing start
2017-07-03
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
40 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
71610-326-602023-01-30C16284748780-1f386c649-f112-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES, USP, safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES, USP. OMEPRAZOLE delayed-release capsules, USP, for oral administration Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-326-60OMEPRAZOLE90 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-326OMEPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 1 package rows20190831_b427aff0-e1ba-4b03-b469-a2e9d9d5f843.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSNb427aff0-e1ba-4b03-b469-a2e9d9d5f8431
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDb427aff0-e1ba-4b03-b469-a2e9d9d5f8431

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-326-607161003266090 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-326-60) 2019-08-150000-00-00NoNoCurrent