FDA.reportPublic FDA data

omeprazole

Product NDC
42507-915
11-digit product format
425070915
Labeler code
42507
Product ID
42507-915_926d7c5a-14db-4560-ac64-898166bf2241
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
HyVee Inc
Application
NDA022032
Marketing category
NDA
Marketing start
2008-03-02
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
omeprazole
Listing expiration
2027-12-31

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
42507-915-00omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE145
42507-915-01omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE15
42507-915-03omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE35
42507-915-30omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE145
42507-915-30omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE25
42507-915-55omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE145
42507-915-55omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE35
42507-915-74omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE145
42507-915-74omeprazole1 in 1 BLISTER PACKTABLET, DELAYED RELEASE15

DailyMed Socrata Ingredients#

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSNa5df7dac-00f4-4d97-9586-cde3055890ac5
402014omeprazole 20 MG Delayed Release Oral TabletSCDa5df7dac-00f4-4d97-9586-cde3055890ac5
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSYa5df7dac-00f4-4d97-9586-cde3055890ac5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42507-915-004250709150014 in 1 BOTTLEHistorical
42507-915-01425070915011 BOTTLE in 1 CARTON (42507-915-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (42507-915-00) 1 bottle2008-03-02NoNoCurrent
42507-915-03425070915033 BOTTLE in 1 CARTON (42507-915-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (42507-915-00) 3 bottle2008-03-02NoNoCurrent
42507-915-304250709153014 in 1 CARTONHistorical
42507-915-55425070915553 CARTON in 1 CARTON (42507-915-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK3 carton2008-03-02NoNoCurrent
42507-915-744250709157414 BLISTER PACK in 1 CARTON (42507-915-74) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK14 blister pack2008-03-02NoNoCurrent