FDA.reportPublic FDA data

omeprazole

Product NDC
59779-503
11-digit product format
597790503
Labeler code
59779
Product ID
59779-503_2d9d60cd-6c79-4da7-9c48-ac1b73df9832
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
CVS Pharmacy
Application
NDA022032
Marketing category
NDA
Marketing start
2008-02-29
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
omeprazole
Listing expiration
2027-12-31

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
59779-503-01omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE1410
59779-503-01omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE110
59779-503-02omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE1410
59779-503-02omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE210
59779-503-03omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE310
59779-503-03omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE1410
59779-503-30omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE210
59779-503-30omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE1410
59779-503-55omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE1410
59779-503-55omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE310
59779-503-74omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE1410
59779-503-74omeprazole1 in 1 BLISTER PACKTABLET, DELAYED RELEASE110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-503OMEPRAZOLE TABLET, DELAYED RELEASE [CVS PHARMACY]9Current NDC, Legacy NDC, 12 package rows20250112_fb3b1c3b-d486-4fa6-9ebf-ee1812ed2512.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSNfb3b1c3b-d486-4fa6-9ebf-ee1812ed251210
402014omeprazole 20 MG Delayed Release Oral TabletSCDfb3b1c3b-d486-4fa6-9ebf-ee1812ed251210
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSYfb3b1c3b-d486-4fa6-9ebf-ee1812ed251210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-503-01597790503011 BOTTLE in 1 CARTON (59779-503-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2012-02-290000-00-00NoNoCurrent
59779-503-02597790503022 BOTTLE in 1 CARTON (59779-503-02) > 14 TABLET, DELAYED RELEASE in 1 BOTTLE2 bottle2012-03-020000-00-00NoNoCurrent
59779-503-03597790503033 BOTTLE in 1 CARTON (59779-503-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2012-02-280000-00-00NoNoCurrent
59779-503-30597790503302 in 1 CARTONHistorical
59779-503-55597790503553 CARTON in 1 CARTON (59779-503-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK3 carton2008-03-050000-00-00NoNoCurrent
59779-503-745977905037414 in 1 CARTONHistorical