FDA.reportPublic FDA data

up and up omeprazole

Product NDC
11673-915
11-digit product format
116730915
Labeler code
11673
Product ID
11673-915_cd15d39d-8e0a-4c39-806a-ff9951f33434
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Target Corporation
Application
NDA022032
Marketing category
NDA
Marketing start
2009-07-14
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
11673-915-01up and up omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE111
11673-915-01up and up omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE1411
11673-915-02up and up omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE211
11673-915-02up and up omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE1411
11673-915-03up and up omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE311
11673-915-03up and up omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE1411
11673-915-30up and up omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE1411
11673-915-30up and up omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE211
11673-915-55up and up omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE311
11673-915-55up and up omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE1411
11673-915-74up and up omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE1411
11673-915-74up and up omeprazole1 in 1 BLISTER PACKTABLET, DELAYED RELEASE111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11673-915-03EA - Each11673-915adfba55d-b908-49f8-8c6a-4f625466c35a12016-04-04
11673-915-30EA - Each11673-91555d47e74-4015-4d9a-a389-415b9646479a12012-07-24
11673-915-55EA - Each11673-915c692b527-0c08-4342-9598-46e4b7de242412012-07-24
11673-915-74EA - Each11673-915fa658b9c-4c88-401f-be60-a43a68db7d4512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9UP AND UP OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TARGET CORPORATION]5
OMEPRAZOLEACTIVE MOIETYKG60484QX9UP AND UP OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TARGET CORPORATION]5
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZUP AND UP OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TARGET CORPORATION]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675UP AND UP OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TARGET CORPORATION]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTUP AND UP OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TARGET CORPORATION]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOUP AND UP OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TARGET CORPORATION]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XUP AND UP OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TARGET CORPORATION]5
MONOETHANOLAMINEINACTIVE INGREDIENT5KV86114PTUP AND UP OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TARGET CORPORATION]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3UP AND UP OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TARGET CORPORATION]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JUP AND UP OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TARGET CORPORATION]5
SODIUM STEARATEINACTIVE INGREDIENTQU7E2XA9TGUP AND UP OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TARGET CORPORATION]5
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIUP AND UP OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TARGET CORPORATION]5
TALCINACTIVE INGREDIENT7SEV7J4R1UUP AND UP OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TARGET CORPORATION]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPUP AND UP OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TARGET CORPORATION]5
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMUP AND UP OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TARGET CORPORATION]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-915UP AND UP OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TARGET CORPORATION]11Current NDC, Legacy NDC, 12 package rows20240927_2f2b26fe-dbc2-4185-8a27-6b166dd49ba2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN2f2b26fe-dbc2-4185-8a27-6b166dd49ba211
402014omeprazole 20 MG Delayed Release Oral TabletSCD2f2b26fe-dbc2-4185-8a27-6b166dd49ba211
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY2f2b26fe-dbc2-4185-8a27-6b166dd49ba211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-915-01116730915011 BOTTLE in 1 CARTON (11673-915-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2013-08-130000-00-00NoNoCurrent
11673-915-02116730915022 in 1 CARTONHistorical
11673-915-03116730915033 BOTTLE in 1 CARTON (11673-915-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2013-08-140000-00-00NoNoCurrent
11673-915-301167309153014 in 1 CARTONHistorical
11673-915-55116730915553 in 1 CARTONHistorical
11673-915-741167309157414 in 1 CARTONHistorical