FDA.reportPublic FDA data

omeprazole

Product NDC
37808-915
11-digit product format
378080915
Labeler code
37808
Product ID
37808-915_0623c22d-32db-42d7-8a2b-d50e96baae5b
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
H E B
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
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
37808-915-01omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE18
37808-915-01omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE148
37808-915-03omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE148
37808-915-03omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE38
37808-915-30omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE148
37808-915-30omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE28
37808-915-55omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE38
37808-915-55omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE148
37808-915-74omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE148
37808-915-74omeprazole1 in 1 BLISTER PACKTABLET, DELAYED RELEASE18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-915OMEPRAZOLE TABLET, DELAYED RELEASE [H E B]8Current NDC, Legacy NDC, 10 package rows20250213_5ceaec04-3ca3-4c7c-9184-51a42686a595.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN5ceaec04-3ca3-4c7c-9184-51a42686a5958
402014omeprazole 20 MG Delayed Release Oral TabletSCD5ceaec04-3ca3-4c7c-9184-51a42686a5958
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY5ceaec04-3ca3-4c7c-9184-51a42686a5958

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-915-01378080915011 BOTTLE in 1 CARTON (37808-915-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2011-02-040000-00-00NoNoCurrent
37808-915-03378080915033 BOTTLE in 1 CARTON (37808-915-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2021-04-270000-00-00NoNoCurrent
37808-915-30378080915302 CARTON in 1 CARTON (37808-915-30) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 carton2008-02-290000-00-00NoNoCurrent
37808-915-55378080915553 CARTON in 1 CARTON (37808-915-55) > 14 BLISTER PACK in 1 CARTON > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK3 carton2008-02-290000-00-00NoNoCurrent
37808-915-743780809157414 BLISTER PACK in 1 CARTON (37808-915-74) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK14 blister pack2008-02-290000-00-00NoNoCurrent