FDA.reportPublic FDA data

omeprazole

Product NDC
11822-1040
11-digit product format
118221040
Labeler code
11822
Product ID
11822-1040_0662e92e-ed7c-48e7-a7f6-7de0b60d06a8
Type
HUMAN OTC DRUG
Nonproprietary name
omeprazole
Dosage form
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route
ORAL
Labeler
Rite Aid Corporation
Application
NDA209400
Marketing category
NDA
Marketing start
2018-03-29
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
Rxcui2003656

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-1040-12023-07-31C16284748780-1f386c649-f5a5-0266-e053-dadaa90a7c1aRite Aid Corporation Omeprazole Drug Facts
11822-1040-22023-07-31C16284748780-1f386c649-f5a5-0266-e053-dadaa90a7c1aRite Aid Corporation Omeprazole Drug Facts
11822-1040-12023-01-30C16284748780-1f386c649-f5a5-0266-e053-dadaa90a7c1aRite Aid Corporation Omeprazole Drug Facts
11822-1040-22023-01-30C16284748780-1f386c649-f5a5-0266-e053-dadaa90a7c1aRite Aid Corporation Omeprazole Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-1040-1omeprazole3 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D35
11822-1040-1omeprazole14 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D145
11822-1040-2omeprazole1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING, D15
11822-1040-2omeprazole14 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D145

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-1040OMEPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [RITE AID CORPORATION]5Current NDC, Legacy NDC, 4 package rows20250205_6919399e-f112-4274-b4de-df0b4c391e63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2003656omeprazole 20 MG Delayed Release Disintegrating Oral TabletPSN6919399e-f112-4274-b4de-df0b4c391e635
2003656omeprazole 20 MG Disintegrating Oral TabletSCD6919399e-f112-4274-b4de-df0b4c391e635
2003656omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Disintegrating Oral TabletSY6919399e-f112-4274-b4de-df0b4c391e635

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-1040-1118221040013 CARTON in 1 CARTON (11822-1040-1) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK3 carton2018-03-290000-00-00NoNoCurrent
11822-1040-21182210400214 BLISTER PACK in 1 CARTON (11822-1040-2) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK14 blister pack2019-03-130000-00-00NoNoCurrent