FDA.reportPublic FDA data

Omeprazole

Product NDC
50436-8158
11-digit product format
504368158
Labeler code
50436
Product ID
50436-8158_b512da3f-010d-4c1e-a041-8dae20fc87ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA075576
Marketing category
ANDA
Marketing start
2009-01-21
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
50436-8158-12023-01-30C16284748780-1f386c64a-1513-0266-e053-dadaa90a7c1aThese 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
50436-8158-22023-01-30C16284748780-1f386c64a-1513-0266-e053-dadaa90a7c1aThese 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
50436-8158-1Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE307
50436-8158-2Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-8158-1EA - Each50436-81588849f4a3-8dff-46f6-88ec-c08ef5ce24cf12021-11-09
50436-8158-2EA - Each50436-815867c9cc9c-a083-49d1-8486-65d878cff9ba12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-8158OMEPRAZOLE CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES]7Legacy NDC, 2 package rows20210919_73f77956-e7e7-4bc2-adab-67b164942d53.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN73f77956-e7e7-4bc2-adab-67b164942d537
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD73f77956-e7e7-4bc2-adab-67b164942d537
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY73f77956-e7e7-4bc2-adab-67b164942d537

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50436-8158-15043681580130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50436-8158-1) 2021-09-170000-00-00NoNoCurrent
50436-8158-25043681580260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50436-8158-2) 2021-09-170000-00-00NoNoCurrent