FDA.reportPublic FDA data

omeprazole

Product NDC
79481-0281
11-digit product format
794810281
Labeler code
79481
Product ID
79481-0281_edbe9a75-73ef-4b53-8f08-10e775091e23
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Meijer, Inc.
Application
ANDA216096
Marketing category
ANDA
Marketing start
2023-08-24
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
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
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-0281-0omeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
79481-0281-1omeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
79481-0281-1omeprazole3 in 1 CARTONCAPSULE, DELAYED RELEASE32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0281OMEPRAZOLE (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [MEIJER, INC.]2Current NDC, 3 package rows20240405_0340ef94-d2b4-47af-a045-d0d031293984.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN0340ef94-d2b4-47af-a045-d0d0312939842
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD0340ef94-d2b4-47af-a045-d0d0312939842
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY0340ef94-d2b4-47af-a045-d0d0312939842

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79481-0281-07948102810014 CAPSULE, DELAYED RELEASE in 1 BOTTLE (79481-0281-0) 2023-08-24NoNoCurrent
79481-0281-1794810281013 BOTTLE in 1 CARTON (79481-0281-1) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2023-08-24NoNoCurrent