FDA.reportPublic FDA data

up and up omeprazole

Product NDC
11673-018
11-digit product format
116730018
Labeler code
11673
Product ID
11673-018_a8a64ea9-0d2c-45d5-a81d-da0d8ce60044
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Target Corporation
Application
NDA022032
Marketing category
NDA
Marketing start
2015-04-17
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-018-01up and up omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE17
11673-018-01up and up omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE147
11673-018-03up and up omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE37
11673-018-03up and up omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE147

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9UP AND UP OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [TARGET CORPORATION]1
OMEPRAZOLEACTIVE MOIETYKG60484QX9UP AND UP OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [TARGET CORPORATION]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHUP AND UP OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [TARGET CORPORATION]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZUP AND UP OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [TARGET CORPORATION]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOUP AND UP OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [TARGET CORPORATION]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XUP AND UP OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [TARGET CORPORATION]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AUP AND UP OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [TARGET CORPORATION]1
MONOETHANOLAMINEINACTIVE INGREDIENT5KV86114PTUP AND UP OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [TARGET CORPORATION]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PUP AND UP OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [TARGET CORPORATION]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JUP AND UP OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [TARGET CORPORATION]1
SODIUM STEARATEINACTIVE INGREDIENTQU7E2XA9TGUP AND UP OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [TARGET CORPORATION]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIUP AND UP OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [TARGET CORPORATION]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4UP AND UP OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [TARGET CORPORATION]1
TALCINACTIVE INGREDIENT7SEV7J4R1UUP AND UP OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [TARGET CORPORATION]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPUP AND UP OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [TARGET CORPORATION]1
TRIACETININACTIVE INGREDIENTXHX3C3X673UP AND UP OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [TARGET CORPORATION]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMUP AND UP OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [TARGET CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-018UP AND UP OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TARGET CORPORATION]7Current NDC, Legacy NDC, 4 package rows20250106_d664c45d-564a-4692-ae8f-8dd980ffcd87.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSNd664c45d-564a-4692-ae8f-8dd980ffcd877
402014omeprazole 20 MG Delayed Release Oral TabletSCDd664c45d-564a-4692-ae8f-8dd980ffcd877
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSYd664c45d-564a-4692-ae8f-8dd980ffcd877

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-018-01116730018011 BOTTLE in 1 CARTON (11673-018-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2017-03-020000-00-00NoNoCurrent
11673-018-03116730018033 BOTTLE in 1 CARTON (11673-018-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2015-04-170000-00-00NoNoCurrent