FDA.reportPublic FDA data

omeprazole

Product NDC
0363-0915
11-digit product format
003630915
Labeler code
0363
Product ID
0363-0915_364bb6a8-58c8-460d-92db-c25b9eed8d2b
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Walgreen Company
Application
NDA022032
Marketing category
NDA
Marketing start
2008-02-27
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
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
0363-0915-01omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE18
0363-0915-01omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE148
0363-0915-03omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE38
0363-0915-03omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE148
0363-0915-30omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE28
0363-0915-30omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE148
0363-0915-55omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE38
0363-0915-55omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE148
0363-0915-74omeprazole1 in 1 BLISTER PACKTABLET, DELAYED RELEASE18
0363-0915-74omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE148

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0915-01EA - Each0363-091513a60aa6-d21a-4180-ae3e-100c46568c0112013-02-13
0363-0915-03EA - Each0363-09153ec5bd17-be09-4c37-b896-53e4d8a079b012012-07-24
0363-0915-30EA - Each0363-091568bca872-af83-4af3-a3de-b068927575b812012-07-24
0363-0915-55EA - Each0363-0915018bcfee-23c5-4654-8274-29b04cecd11712012-07-24
0363-0915-74EA - Each0363-0915df547027-e045-4653-946a-0e1b90a6790c12012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0915OMEPRAZOLE TABLET, DELAYED RELEASE [WALGREEN COMPANY]8Current NDC, Legacy NDC, 10 package rows20241225_30a893d2-198a-4184-81b4-02399324ff29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN30a893d2-198a-4184-81b4-02399324ff298
402014omeprazole 20 MG Delayed Release Oral TabletSCD30a893d2-198a-4184-81b4-02399324ff298
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY30a893d2-198a-4184-81b4-02399324ff298

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0915-01003630915011 BOTTLE in 1 CARTON (0363-0915-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2010-10-060000-00-00NoNoCurrent
0363-0915-03003630915033 BOTTLE in 1 CARTON (0363-0915-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2011-03-250000-00-00NoNoCurrent
0363-0915-30003630915302 CARTON in 1 CARTON (0363-0915-30) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 carton2008-02-270000-00-00NoNoCurrent
0363-0915-55003630915553 CARTON in 1 CARTON (0363-0915-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK3 carton2008-02-270000-00-00NoNoCurrent
0363-0915-74003630915741 in 1 BLISTER PACKHistorical