FDA.reportPublic FDA data

Omeprazole

Product NDC
50090-0828
11-digit product format
500900828
Labeler code
50090
Product ID
50090-0828_9b12f61d-9833-4378-81ed-a6094b2abea6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075410
Marketing category
ANDA
Marketing start
2002-11-04
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
50090-0828-02023-01-30C16284748780-1f386c64a-40fd-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 USP Initial U.S. Approval: 1989
50090-0828-22023-01-30C16284748780-1f386c64a-40fd-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 USP Initial U.S. Approval: 1989
50090-0828-32023-01-30C16284748780-1f386c64a-40fd-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 USP Initial U.S. Approval: 1989
50090-0828-42023-01-30C16284748780-1f386c64a-40fd-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 USP Initial U.S. Approval: 1989
50090-0828-52023-01-30C16284748780-1f386c64a-40fd-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 USP Initial U.S. Approval: 1989
50090-0828-62023-01-30C16284748780-1f386c64a-40fd-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 USP Initial U.S. Approval: 1989
50090-0828-72023-01-30C16284748780-1f386c64a-40fd-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 USP Initial U.S. Approval: 1989
50090-0828-82023-01-30C16284748780-1f386c64a-40fd-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 USP Initial U.S. Approval: 1989
50090-0828-92023-01-30C16284748780-1f386c64a-40fd-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 USP Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0828-0Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE304
50090-0828-2Omeprazole15 in 1 BOTTLECAPSULE, DELAYED RELEASE154
50090-0828-3Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE604
50090-0828-4Omeprazole20 in 1 BOTTLECAPSULE, DELAYED RELEASE204
50090-0828-5Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE904
50090-0828-6Omeprazole200 in 1 BOTTLECAPSULE, DELAYED RELEASE2004
50090-0828-7Omeprazole180 in 1 BOTTLECAPSULE, DELAYED RELEASE1804
50090-0828-8Omeprazole7 in 1 BOTTLECAPSULE, DELAYED RELEASE74
50090-0828-9Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0828-0EA - Each50090-0828fda0b116-39c8-4f0b-80f9-ebb66d20175b12021-08-05
50090-0828-2EA - Each50090-082820cf2168-40a7-4927-b8af-f84cfbf8ab2c12021-05-05
50090-0828-3EA - Each50090-0828ffe928fb-4df4-4b48-9ff8-9ea24a0f3c1412021-08-05
50090-0828-5EA - Each50090-08287185ad00-fc35-4cc0-9a58-95ffa486c30612021-06-02
50090-0828-6EA - Each50090-08280f1cbe98-2be0-4727-bded-c5b7e2c60c4512021-08-05
50090-0828-7EA - Each50090-0828c5c66627-8cac-4788-85a5-faf9ea0fda0812021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0828OMEPRAZOLE CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]4Legacy NDC, 9 package rows20210415_ec186fab-6e59-42ef-ae27-f9d620618c72.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNec186fab-6e59-42ef-ae27-f9d620618c724
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDec186fab-6e59-42ef-ae27-f9d620618c724
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYec186fab-6e59-42ef-ae27-f9d620618c724

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0828-05009008280030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-0828-0) 2014-11-280000-00-00NoNoCurrent
50090-0828-25009008280215 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-0828-2) 2014-11-280000-00-00NoNoCurrent
50090-0828-35009008280360 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-0828-3) 2014-11-280000-00-00NoNoCurrent
50090-0828-45009008280420 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-0828-4) 2014-11-280000-00-00NoNoCurrent
50090-0828-55009008280590 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-0828-5) 2014-11-280000-00-00NoNoCurrent
50090-0828-650090082806200 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-0828-6) 2014-11-280000-00-00NoNoCurrent
50090-0828-750090082807180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-0828-7) 2014-11-280000-00-00NoNoCurrent
50090-0828-8500900828087 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-0828-8) 2014-11-280000-00-00NoNoCurrent
50090-0828-950090082809120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-0828-9) 2019-10-100000-00-00NoNoCurrent