FDA.reportPublic FDA data

omeprazole

Product NDC
37808-354
11-digit product format
378080354
Labeler code
37808
Product ID
37808-354_51d6a6ce-e096-4152-876e-472f6b47e5bb
Type
HUMAN OTC DRUG
Nonproprietary name
omeprazole
Dosage form
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route
ORAL
Labeler
H E B
Application
NDA209400
Marketing category
NDA
Marketing start
2018-03-05
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-354-55omeprazole1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING, D14
37808-354-55omeprazole42 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D424
37808-354-74omeprazole14 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D144
37808-354-74omeprazole1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING, D14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-354OMEPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [H E B]4Current NDC, Legacy NDC, 4 package rows20250205_344b5548-e5c0-45bf-bc3f-73af50bd5913.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2003656omeprazole 20 MG Delayed Release Disintegrating Oral TabletPSN344b5548-e5c0-45bf-bc3f-73af50bd59134
2003656omeprazole 20 MG Disintegrating Oral TabletSCD344b5548-e5c0-45bf-bc3f-73af50bd59134
2003656omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Disintegrating Oral TabletSY344b5548-e5c0-45bf-bc3f-73af50bd59134

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-354-553780803545542 BLISTER PACK in 1 CARTON (37808-354-55) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK42 blister pack2018-03-050000-00-00NoNoCurrent
37808-354-743780803547414 BLISTER PACK in 1 CARTON (37808-354-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK14 blister pack2018-03-050000-00-00NoNoCurrent