FDA.reportPublic FDA data

up and up omeprazole

Product NDC
11673-346
11-digit product format
116730346
Labeler code
11673
Product ID
11673-346_dc644613-1131-499d-9c16-7ee241a10c26
Type
HUMAN OTC DRUG
Nonproprietary name
omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Target Corporation
Application
NDA022032
Marketing category
NDA
Marketing start
2022-02-03
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
up and up 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
11673-346-03up and up omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE143
11673-346-03up and up omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-346UP AND UP OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TARGET CORPORATION]3Current NDC, Legacy NDC, 2 package rows20240811_7dc339da-e90b-452b-b25e-8d7f3aa8bc18.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN7dc339da-e90b-452b-b25e-8d7f3aa8bc183
402014omeprazole 20 MG Delayed Release Oral TabletSCD7dc339da-e90b-452b-b25e-8d7f3aa8bc183
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY7dc339da-e90b-452b-b25e-8d7f3aa8bc183

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-346-03116730346033 BOTTLE in 1 CARTON (11673-346-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2022-02-030000-00-00NoNoCurrent