FDA.reportPublic FDA data

omeprazole

Product NDC
11822-1190
11-digit product format
118221190
Labeler code
11822
Product ID
11822-1190_e00e0544-dee7-4322-aa62-e1b912f2e6cf
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
2022-04-13
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-1190-0omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE143
11822-1190-1omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-1190OMEPRAZOLE TABLET, DELAYED RELEASE [RITE AID CORPORATION]3Current NDC, Legacy NDC, 2 package rows20250125_28a0b4c8-3ad3-451c-a957-28aef5e3d8b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN28a0b4c8-3ad3-451c-a957-28aef5e3d8b53
402014omeprazole 20 MG Delayed Release Oral TabletSCD28a0b4c8-3ad3-451c-a957-28aef5e3d8b53
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY28a0b4c8-3ad3-451c-a957-28aef5e3d8b53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-1190-01182211900014 in 1 BOTTLEHistorical
11822-1190-1118221190013 BOTTLE in 1 CARTON (11822-1190-1) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (11822-1190-0) 3 bottle2022-04-130000-00-00NoNoCurrent