FDA.reportPublic FDA data

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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct11822-0915DDiscontinued by firm2026-07-31
excluded packagepackage11822-091511822-0915-1DDiscontinued by firm2026-07-31
excluded packagepackage11822-091511822-0915-2DDiscontinued by firm2026-07-31
excluded packagepackage11822-091511822-0915-3DDiscontinued by firm2026-07-31
excluded packagepackage11822-091511822-0915-4DDiscontinued by firm2026-07-31
excluded packagepackage11822-091511822-0915-5DDiscontinued by firm2026-07-31
excluded packagepackage11822-091511822-0915-6DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022032-001OMEPRAZOLEOMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022032-001125995652030-01-31Drug product2026-05-11

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N022032-001125995652030-01-31Drug product2026-05-11a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 3 · 58 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Berkley and Jensen OmeprazoleOMEPRAZOLEBJWCf74752a8-a686-4c7d-91ad-8c87c4596a7a2026-05-21WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
care one omeprazoleOMEPRAZOLEAmerican Sales Companydb2d75ea-5924-4b7f-a92d-d4847a010d522026-04-17WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
omeprazoleOMEPRAZOLERite Aid Corporationee853401-b641-4dab-b708-29424c2d0b792026-03-25WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
omeprazoleOMEPRAZOLEHyVee Inca5df7dac-00f4-4d97-9586-cde3055890ac2026-02-04WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
omeprazoleOMEPRAZOLEHyVee Inccf9919e6-a839-4bad-a007-80d5bf6f81db2026-01-30WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
good neighbor pharmacy omeprazoleOMEPRAZOLEAmerisource Bergenf9aab207-d309-49b5-b941-c2912b1865832025-12-21WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
omeprazoleOMEPRAZOLEKroger Company015b1c8f-9d5b-4afc-a55c-1a731b5fc72a2025-12-08WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
dg health omeprazoleOMEPRAZOLEDolgencorp, LLC326bf21c-fad4-473e-9e7f-797319d4353a2025-09-02WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
omeprazoleOMEPRAZOLEKroger Companyda18d91c-5fe9-44d4-9d6f-602900af3f082025-06-04WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
careone omeprazoleOMEPRAZOLERetail Business Services, LLC063cfad8-3ca6-4b72-a4c9-512b8047bae32025-04-17WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
leader omeprazoleOMEPRAZOLECardinal Health 110, LLC. dba Leader19beab17-ca25-4be3-bada-20a2e9aa26b52025-04-16WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
rugby omeprazoleOMEPRAZOLERugby Laboratories61952807-f38d-4e7a-8646-a8ec85d7fb372025-04-15WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
careone omeprazoleOMEPRAZOLEAmerican Sales Companya5ec923a-dbc7-43e0-b3b8-f61dcaa6765d2025-04-14WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
signature care omeprazoleOMEPRAZOLESafeway85ece978-3cfb-4c09-bf0f-3217fda8e7d42025-04-14WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
equate omeprazoleOMEPRAZOLEWALMART INC.dcfe8e94-9c88-464e-9a80-3baa9c4755d92025-03-27WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
equate omeprazoleOMEPRAZOLEWal-Mart Stores Inc504b8282-d93f-454f-9f93-84cb8a9105d72025-03-25WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
omeprazoleOMEPRAZOLEH E B501d80c0-68ee-4fd9-bc56-0b214dbf72b52025-02-27WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
omeprazoleOMEPRAZOLEPadagis Israel Pharmaceuticals Ltdcb47354c-297b-4dc2-85af-242acc967b562025-02-06WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
Signature Care OmeprazoleOMEPRAZOLESafeway6361a492-782f-4608-a20f-1bd86afbd8642025-02-06WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
omeprazoleOMEPRAZOLEH E B5ceaec04-3ca3-4c7c-9184-51a42686a5952025-02-05WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032

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