omeprazole

Product NDC
79481-3023
11-digit product format
794813023
Labeler code
79481
Product ID
79481-3023_d9659b73-1336-4777-8ce9-926b851e1616
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Meijer, Inc.
Application
ANDA216096
Marketing category
ANDA
Marketing start
2026-01-29
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
omeprazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE MAGNESIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii426QFE7XLK
Rxcui198051

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
79481-3023-0omeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
79481-3023-1omeprazole3 in 1 CARTONCAPSULE, DELAYED RELEASE32

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN47c41c68-cb20-40f0-9d85-ea8db33284782
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD47c41c68-cb20-40f0-9d85-ea8db33284782
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY47c41c68-cb20-40f0-9d85-ea8db33284782

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79481-3023-07948130230014 in 1 BOTTLEHistorical
79481-3023-1794813023013 BOTTLE in 1 CARTON (79481-3023-1) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (79481-3023-0) 3 bottle2026-01-29NoNoCurrent