FDA.reportPublic FDA data

omeprazole

Product NDC
11822-0453
11-digit product format
118220453
Labeler code
11822
Product ID
11822-0453_b518a17f-c0c9-4f15-884f-e2b193115a96
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
2015-03-26
Marketing end
2026-10-01
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
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11822-045311822-0453-1DDiscontinued by firm2026-08-03
excluded packagepackage11822-045311822-0453-3DDiscontinued by firm2026-08-03

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
ndc (product): 11822-0453
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

Additional Listing Data#

Finished product
Yes
Brand name base
omeprazole

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
KG60484QX9Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
402014Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ee853401-b641-4dab-b708-29424c2d0b79Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-0453-12023-06-26C16284748780-1f386c649-ea44-0266-e053-dadaa90a7c1aRite Aid Corporation Omeprazole Drug Facts
11822-0453-22023-06-26C16284748780-1f386c649-ea44-0266-e053-dadaa90a7c1aRite Aid Corporation Omeprazole Drug Facts
11822-0453-12023-01-30C16284748780-1f386c649-ea44-0266-e053-dadaa90a7c1aRite Aid Corporation Omeprazole Drug Facts
11822-0453-22023-01-30C16284748780-1f386c649-ea44-0266-e053-dadaa90a7c1aRite Aid Corporation Omeprazole Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0453-1omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE147
11822-0453-1omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE37
11822-0453-2omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE147
11822-0453-2omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE17
11822-0453-3omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE147
11822-0453-3omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE27

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [RITE AID CORPORATION]1
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [RITE AID CORPORATION]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHOMEPRAZOLE CAPSULE, DELAYED RELEASE [RITE AID CORPORATION]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZOMEPRAZOLE CAPSULE, DELAYED RELEASE [RITE AID CORPORATION]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOMEPRAZOLE CAPSULE, DELAYED RELEASE [RITE AID CORPORATION]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOMEPRAZOLE CAPSULE, DELAYED RELEASE [RITE AID CORPORATION]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AOMEPRAZOLE CAPSULE, DELAYED RELEASE [RITE AID CORPORATION]1
MONOETHANOLAMINEINACTIVE INGREDIENT5KV86114PTOMEPRAZOLE CAPSULE, DELAYED RELEASE [RITE AID CORPORATION]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5POMEPRAZOLE CAPSULE, DELAYED RELEASE [RITE AID CORPORATION]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOMEPRAZOLE CAPSULE, DELAYED RELEASE [RITE AID CORPORATION]1
SODIUM STEARATEINACTIVE INGREDIENTQU7E2XA9TGOMEPRAZOLE CAPSULE, DELAYED RELEASE [RITE AID CORPORATION]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIOMEPRAZOLE CAPSULE, DELAYED RELEASE [RITE AID CORPORATION]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4OMEPRAZOLE CAPSULE, DELAYED RELEASE [RITE AID CORPORATION]1
TALCINACTIVE INGREDIENT7SEV7J4R1UOMEPRAZOLE CAPSULE, DELAYED RELEASE [RITE AID CORPORATION]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [RITE AID CORPORATION]1
TRIACETININACTIVE INGREDIENTXHX3C3X673OMEPRAZOLE CAPSULE, DELAYED RELEASE [RITE AID CORPORATION]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [RITE AID CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0453OMEPRAZOLE TABLET, DELAYED RELEASE [RITE AID CORPORATION]6Current NDC, Legacy NDC, 6 package rows20231114_ee853401-b641-4dab-b708-29424c2d0b79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSNee853401-b641-4dab-b708-29424c2d0b797
402014omeprazole 20 MG Delayed Release Oral TabletSCDee853401-b641-4dab-b708-29424c2d0b797
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSYee853401-b641-4dab-b708-29424c2d0b797

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0453-1118220453013 BOTTLE in 1 CARTON (11822-0453-1) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2015-03-262026-08-01NoNoCurrent
11822-0453-2118220453021 BOTTLE in 1 CARTON (11822-0453-2) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2017-03-202026-10-01NoNoCurrent
11822-0453-3118220453032 BOTTLE in 1 CARTON (11822-0453-3) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE2 bottle2023-07-272026-08-01NoNoHistorical