FDA.reportPublic FDA data

dg health omeprazole

Product NDC
55910-915
11-digit product format
559100915
Labeler code
55910
Product ID
55910-915_4900f1e8-5133-4ef9-a871-4d88507d56eb
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Dolgencorp, LLC
Application
NDA022032
Marketing category
NDA
Marketing start
2010-02-14
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
dg health 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
55910-915-01dg health omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE19
55910-915-01dg health omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE149
55910-915-02dg health omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE29
55910-915-02dg health omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE149
55910-915-03dg health omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE149
55910-915-03dg health omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE39
55910-915-30dg health omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE149
55910-915-30dg health omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE29
55910-915-74dg health omeprazole1 in 1 BLISTER PACKTABLET, DELAYED RELEASE19
55910-915-74dg health omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE149

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9DG HEALTH OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DOLGENCORP, LLC]4
OMEPRAZOLEACTIVE MOIETYKG60484QX9DG HEALTH OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DOLGENCORP, LLC]4
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZDG HEALTH OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DOLGENCORP, LLC]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DG HEALTH OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DOLGENCORP, LLC]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDG HEALTH OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DOLGENCORP, LLC]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODG HEALTH OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DOLGENCORP, LLC]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDG HEALTH OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DOLGENCORP, LLC]4
MONOETHANOLAMINEINACTIVE INGREDIENT5KV86114PTDG HEALTH OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DOLGENCORP, LLC]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DG HEALTH OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DOLGENCORP, LLC]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDG HEALTH OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DOLGENCORP, LLC]4
SODIUM STEARATEINACTIVE INGREDIENTQU7E2XA9TGDG HEALTH OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DOLGENCORP, LLC]4
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIDG HEALTH OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DOLGENCORP, LLC]4
TALCINACTIVE INGREDIENT7SEV7J4R1UDG HEALTH OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DOLGENCORP, LLC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDG HEALTH OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DOLGENCORP, LLC]4
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDG HEALTH OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DOLGENCORP, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-915DG HEALTH OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DOLGENCORP, LLC]8Current NDC, Legacy NDC, 10 package rows20241208_326bf21c-fad4-473e-9e7f-797319d4353a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN326bf21c-fad4-473e-9e7f-797319d4353a9
402014omeprazole 20 MG Delayed Release Oral TabletSCD326bf21c-fad4-473e-9e7f-797319d4353a9
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY326bf21c-fad4-473e-9e7f-797319d4353a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-915-01559100915011 in 1 CARTONHistorical
55910-915-02559100915022 BOTTLE in 1 CARTON (55910-915-02) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE2 bottle2012-05-200000-00-00NoNoCurrent
55910-915-03559100915033 BOTTLE in 1 CARTON (55910-915-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2013-07-240000-00-00NoNoCurrent
55910-915-30559100915302 CARTON in 1 CARTON (55910-915-30) > 14 BLISTER PACK in 1 CARTON > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 carton2011-06-130000-00-00NoNoCurrent
55910-915-745591009157414 BLISTER PACK in 1 CARTON (55910-915-74) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK14 blister pack2010-02-140000-00-00NoNoCurrent