FDA.reportPublic FDA data

Omeprazole

Product NDC
42254-043
11-digit product format
422540043
Labeler code
42254
Product ID
42254-043_fac73e19-3809-4846-8abc-f42a47c224ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA075576
Marketing category
ANDA
Marketing start
2007-10-22
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
10 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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
42254-043-602019-09-24C16284748780-19350213a-3cec-c013-e053-90daa90a1393Omeprazole Delayed-Release Capsules These highlights do not include all the information needed to use See full prescribing information for use INITIAL U.S. APPROVAL: 2007
42254-043-722019-09-24C16284748780-19350213a-3cec-c013-e053-90daa90a1393Omeprazole Delayed-Release Capsules These highlights do not include all the information needed to use See full prescribing information for use INITIAL U.S. APPROVAL: 2007

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-043-60Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE602
42254-043-72Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-043OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]2Legacy NDC, 2 package rows20120621_60752a58-1d6c-4b4d-98dd-d49c76d2f443.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199119omeprazole 10 MG Delayed Release Oral CapsulePSN60752a58-1d6c-4b4d-98dd-d49c76d2f4432
198051omeprazole 20 MG Delayed Release Oral CapsulePSN60752a58-1d6c-4b4d-98dd-d49c76d2f4432
199119omeprazole 10 MG Delayed Release Oral CapsuleSCD60752a58-1d6c-4b4d-98dd-d49c76d2f4432
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD60752a58-1d6c-4b4d-98dd-d49c76d2f4432
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSY60752a58-1d6c-4b4d-98dd-d49c76d2f4432
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY60752a58-1d6c-4b4d-98dd-d49c76d2f4432

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-043-604225400436060 in 1 BOTTLEHistorical
42254-043-7242254004372120 in 1 BOTTLEHistorical