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

Additional Listing Data#

Finished product
Yes
Brand name base
omeprazole

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
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 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