omeprazole

Product NDC
11822-0915
11-digit product format
118220915
Labeler code
11822
Product ID
11822-0915_d6ea9fab-5820-401b-9ed1-a36b95afc717
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Rite Aid Corporation
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-0915-12023-11-02C16284748780-1f386c649-aec4-0266-e053-dadaa90a7c1aRite Aid Corporation Omeprazole Delayed Release Tablets 20 mg Drug Facts
11822-0915-22023-11-02C16284748780-1f386c649-aec4-0266-e053-dadaa90a7c1aRite Aid Corporation Omeprazole Delayed Release Tablets 20 mg Drug Facts
11822-0915-32023-11-02C16284748780-1f386c649-aec4-0266-e053-dadaa90a7c1aRite Aid Corporation Omeprazole Delayed Release Tablets 20 mg Drug Facts
11822-0915-42023-11-02C16284748780-1f386c649-aec4-0266-e053-dadaa90a7c1aRite Aid Corporation Omeprazole Delayed Release Tablets 20 mg Drug Facts
11822-0915-52023-11-02C16284748780-1f386c649-aec4-0266-e053-dadaa90a7c1aRite Aid Corporation Omeprazole Delayed Release Tablets 20 mg Drug Facts
11822-0915-62023-11-02C16284748780-1f386c649-aec4-0266-e053-dadaa90a7c1aRite Aid Corporation Omeprazole Delayed Release Tablets 20 mg Drug Facts
11822-0915-12023-01-30C16284748780-1f386c649-aec4-0266-e053-dadaa90a7c1aRite Aid Corporation Omeprazole Delayed Release Tablets 20 mg Drug Facts
11822-0915-22023-01-30C16284748780-1f386c649-aec4-0266-e053-dadaa90a7c1aRite Aid Corporation Omeprazole Delayed Release Tablets 20 mg Drug Facts
11822-0915-32023-01-30C16284748780-1f386c649-aec4-0266-e053-dadaa90a7c1aRite Aid Corporation Omeprazole Delayed Release Tablets 20 mg Drug Facts
11822-0915-42023-01-30C16284748780-1f386c649-aec4-0266-e053-dadaa90a7c1aRite Aid Corporation Omeprazole Delayed Release Tablets 20 mg Drug Facts
11822-0915-52023-01-30C16284748780-1f386c649-aec4-0266-e053-dadaa90a7c1aRite Aid Corporation Omeprazole Delayed Release Tablets 20 mg Drug Facts
11822-0915-62023-01-30C16284748780-1f386c649-aec4-0266-e053-dadaa90a7c1aRite Aid Corporation Omeprazole Delayed Release Tablets 20 mg Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0915-1omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE27
11822-0915-1omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE147
11822-0915-2omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE147
11822-0915-2omeprazole1 in 1 BLISTER PACKTABLET, DELAYED RELEASE17
11822-0915-3omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE37
11822-0915-3omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE147
11822-0915-4omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE147
11822-0915-4omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE27
11822-0915-5omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE17
11822-0915-5omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE147
11822-0915-6omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE147
11822-0915-6omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE37

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0915OMEPRAZOLE TABLET, DELAYED RELEASE [RITE AID CORPORATION]7Current NDC, Legacy NDC, 12 package rows20231103_4bb2866d-15b5-42a2-8cda-c7d41259a4af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN4bb2866d-15b5-42a2-8cda-c7d41259a4af7
402014omeprazole 20 MG Delayed Release Oral TabletSCD4bb2866d-15b5-42a2-8cda-c7d41259a4af7
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY4bb2866d-15b5-42a2-8cda-c7d41259a4af7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0915-1118220915012 CARTON in 1 CARTON (11822-0915-1) > 14 BLISTER PACK in 1 CARTON > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 carton2008-02-270000-00-00NoNoCurrent
11822-0915-21182209150214 BLISTER PACK in 1 CARTON (11822-0915-2) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK14 blister pack2008-02-250000-00-00NoNoCurrent
11822-0915-3118220915033 CARTON in 1 CARTON (11822-0915-3) > 14 BLISTER PACK in 1 CARTON > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK3 carton2008-02-270000-00-00NoNoCurrent
11822-0915-4118220915042 BOTTLE in 1 CARTON (11822-0915-4) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE2 bottle2011-12-270000-00-00NoNoCurrent
11822-0915-5118220915051 BOTTLE in 1 CARTON (11822-0915-5) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2011-12-270000-00-00NoNoCurrent
11822-0915-6118220915063 BOTTLE in 1 CARTON (11822-0915-6) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2011-12-270000-00-00NoNoCurrent