FDA.reportPublic FDA data

24 hr omeprazole

Product NDC
79481-0075
11-digit product format
794810075
Labeler code
79481
Product ID
79481-0075_9dee9797-6b74-498a-9237-53ac64642d27
Type
HUMAN OTC DRUG
Nonproprietary name
omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Meijer, Inc.
Application
NDA022032
Marketing category
NDA
Marketing start
2022-05-25
Substance
OMEPRAZOLE
Active strength
20 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
24 hr omeprazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui402014

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
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-0075-124 hr omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE143
79481-0075-324 hr omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE143
79481-0075-324 hr omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-007524 HR OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [MEIJER, INC.]3Current NDC, Legacy NDC, 3 package rows20250125_36adb053-3189-4c91-87dd-e122a2c8e812.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN36adb053-3189-4c91-87dd-e122a2c8e8123
402014omeprazole 20 MG Delayed Release Oral TabletSCD36adb053-3189-4c91-87dd-e122a2c8e8123
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY36adb053-3189-4c91-87dd-e122a2c8e8123

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79481-0075-17948100750114 TABLET, DELAYED RELEASE in 1 BOTTLE (79481-0075-1) 2022-05-250000-00-00NoNoCurrent
79481-0075-3794810075033 BOTTLE in 1 CARTON (79481-0075-3) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2022-05-250000-00-00NoNoCurrent