24 HOUR Omeprazole

Product NDC
85828-731
11-digit product format
858280731
Labeler code
85828
Product ID
85828-731_4db11e95-b324-1be9-e063-6294a90a5586
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole 20 mg
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Grocery Outlet, Inc.
Application
ANDA218829
Marketing category
ANDA
Marketing start
2026-03-25
Substance
OMEPRAZOLE MAGNESIUM
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
24 HOUR Omeprazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE MAGNESIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii426QFE7XLK
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85828-731-4524 HOUR Omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE12
85828-731-4524 HOUR Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE142

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN4466f17c-c27b-8393-e063-6394a90a803d2
402014omeprazole 20 MG Delayed Release Oral TabletSCD4466f17c-c27b-8393-e063-6394a90a803d2
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY4466f17c-c27b-8393-e063-6394a90a803d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85828-731-45858280731451 BOTTLE in 1 CARTON (85828-731-45) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2026-03-25NoNoHistorical