FDA.reportPublic FDA data

omeprazole

Product NDC
30142-557
11-digit product format
301420557
Labeler code
30142
Product ID
30142-557_ca200f16-7b7e-4b33-964b-e2ccfc62f0f4
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Kroger Company
Application
NDA022032
Marketing category
NDA
Marketing start
2008-02-25
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
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
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
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-557-01omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE19
30142-557-01omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE149
30142-557-02omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE149
30142-557-02omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE29
30142-557-03omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE149
30142-557-03omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE39
30142-557-30omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE149
30142-557-30omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE29
30142-557-55omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE149
30142-557-55omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE39
30142-557-74omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE149
30142-557-74omeprazole1 in 1 BLISTER PACKTABLET, DELAYED RELEASE19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE TABLET, DELAYED RELEASE [KROGER COMPANY]3
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE TABLET, DELAYED RELEASE [KROGER COMPANY]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZOMEPRAZOLE TABLET, DELAYED RELEASE [KROGER COMPANY]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OMEPRAZOLE TABLET, DELAYED RELEASE [KROGER COMPANY]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOMEPRAZOLE TABLET, DELAYED RELEASE [KROGER COMPANY]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOMEPRAZOLE TABLET, DELAYED RELEASE [KROGER COMPANY]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOMEPRAZOLE TABLET, DELAYED RELEASE [KROGER COMPANY]3
MONOETHANOLAMINEINACTIVE INGREDIENT5KV86114PTOMEPRAZOLE TABLET, DELAYED RELEASE [KROGER COMPANY]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE TABLET, DELAYED RELEASE [KROGER COMPANY]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOMEPRAZOLE TABLET, DELAYED RELEASE [KROGER COMPANY]3
SODIUM STEARATEINACTIVE INGREDIENTQU7E2XA9TGOMEPRAZOLE TABLET, DELAYED RELEASE [KROGER COMPANY]3
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIOMEPRAZOLE TABLET, DELAYED RELEASE [KROGER COMPANY]3
TALCINACTIVE INGREDIENT7SEV7J4R1UOMEPRAZOLE TABLET, DELAYED RELEASE [KROGER COMPANY]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE TABLET, DELAYED RELEASE [KROGER COMPANY]3
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE TABLET, DELAYED RELEASE [KROGER COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-557OMEPRAZOLE TABLET, DELAYED RELEASE [KROGER COMPANY]8Current NDC, Legacy NDC, 12 package rows20241225_015b1c8f-9d5b-4afc-a55c-1a731b5fc72a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN015b1c8f-9d5b-4afc-a55c-1a731b5fc72a9
402014omeprazole 20 MG Delayed Release Oral TabletSCD015b1c8f-9d5b-4afc-a55c-1a731b5fc72a9
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY015b1c8f-9d5b-4afc-a55c-1a731b5fc72a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-557-01301420557011 BOTTLE in 1 CARTON (30142-557-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2010-10-080000-00-00NoNoCurrent
30142-557-02301420557022 BOTTLE in 1 CARTON (30142-557-02) > 14 TABLET, DELAYED RELEASE in 1 BOTTLE2 bottle2012-01-030000-00-00NoNoCurrent
30142-557-03301420557033 BOTTLE in 1 CARTON (30142-557-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2012-01-030000-00-00NoNoCurrent
30142-557-30301420557302 CARTON in 1 CARTON (30142-557-30) > 14 BLISTER PACK in 1 CARTON > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 carton2008-02-250000-00-00NoNoCurrent
30142-557-55301420557553 CARTON in 1 CARTON (30142-557-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK3 carton2008-02-250000-00-00NoNoCurrent
30142-557-743014205577414 BLISTER PACK in 1 CARTON (30142-557-74) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK14 blister pack2008-02-250000-00-00NoNoCurrent