FDA.reportPublic FDA data

Omeprazole

Product NDC
50090-1370
11-digit product format
500901370
Labeler code
50090
Product ID
50090-1370_c361a8a8-0543-48b1-a5ce-bc52d000fb96
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
2009-01-23
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1370-02023-01-30C16284748780-1f386c64a-47ee-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
50090-1370-12023-01-30C16284748780-1f386c64a-47ee-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
50090-1370-22023-01-30C16284748780-1f386c64a-47ee-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
50090-1370-0Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3010
50090-1370-1Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3010
50090-1370-2Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE9010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1370OMEPRAZOLE CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]10Legacy NDC, 3 package rows20210416_0d3e1664-078f-4761-9fe2-fee36d6262f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSN0d3e1664-078f-4761-9fe2-fee36d6262f110
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD0d3e1664-078f-4761-9fe2-fee36d6262f110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1370-05009013700030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-1370-0) 2014-11-280000-00-00NoNoCurrent
50090-1370-15009013700130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-1370-1) 2019-02-060000-00-00NoNoCurrent
50090-1370-25009013700290 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-1370-2) 2014-11-280000-00-00NoNoCurrent