FDA.reportPublic FDA data

OMEPRAZOLE

Product NDC
61919-807
11-digit product format
619190807
Labeler code
61919
Product ID
61919-807_c1c32551-46ab-71b3-e053-2a95a90ae99b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OMEPRAZOLE
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
DirexctRX
Application
ANDA091672
Marketing category
ANDA
Marketing start
2019-05-02
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
2022-12-31
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
61919-807-072025-01-30C16284748780-12cef2736-b1c6-d83d-e063-dadaa90ab31fOMEPRAZOLE DR
61919-807-152025-01-30C16284748780-12cef2736-b1c6-d83d-e063-dadaa90ab31fOMEPRAZOLE DR
61919-807-302025-01-30C16284748780-12cef2736-b1c6-d83d-e063-dadaa90ab31fOMEPRAZOLE DR
61919-807-602025-01-30C16284748780-12cef2736-b1c6-d83d-e063-dadaa90ab31fOMEPRAZOLE DR
61919-807-902025-01-30C16284748780-12cef2736-b1c6-d83d-e063-dadaa90ab31fOMEPRAZOLE DR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-807-07OMEPRAZOLEDR7 in 1 BOTTLECAPSULE, DELAYED RELEASE75
61919-807-15OMEPRAZOLEDR15 in 1 BOTTLECAPSULE, DELAYED RELEASE155
61919-807-30OMEPRAZOLEDR30 in 1 BOTTLECAPSULE, DELAYED RELEASE305
61919-807-60OMEPRAZOLEDR60 in 1 BOTTLECAPSULE, DELAYED RELEASE605
61919-807-90OMEPRAZOLEDR90 in 1 BOTTLECAPSULE, DELAYED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-807-07EA - Each61919-8075f3307e5-6817-4ec9-abe7-d45f75a2ed5612021-06-02
61919-807-15EA - Each61919-80731daa0c2-6e8e-4db7-bf79-6d16f57a0f8c12020-02-13
61919-807-30EA - Each61919-807c73deea6-a3cf-40f0-8bbd-18093e7a6a6312019-07-02
61919-807-60EA - Each61919-80722183269-d1e1-4f47-ba9e-b261f82ccd5912020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-807OMEPRAZOLE DR (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [DIREXCTRX]5Legacy NDC, 5 package rows20230520_87e91beb-e8ed-17ac-e053-2995a90a4ba8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN87e91beb-e8ed-17ac-e053-2995a90a4ba85
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD87e91beb-e8ed-17ac-e053-2995a90a4ba85
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY87e91beb-e8ed-17ac-e053-2995a90a4ba85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-807-07619190807077 CAPSULE, DELAYED RELEASE in 1 BOTTLE (61919-807-07) 2019-05-020000-00-00NoNoCurrent
61919-807-156191908071515 CAPSULE, DELAYED RELEASE in 1 BOTTLE (61919-807-15) 2019-05-020000-00-00NoNoCurrent
61919-807-306191908073030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (61919-807-30) 2019-05-020000-00-00NoNoCurrent
61919-807-606191908076060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (61919-807-60) 2019-05-020000-00-00NoNoCurrent
61919-807-906191908079090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (61919-807-90) 2019-05-020000-00-00NoNoCurrent