FDA.reportPublic FDA data

Leader Omeprazole

Product NDC
70000-0381
11-digit product format
700000381
Labeler code
70000
Product ID
70000-0381_867caf67-b128-4c09-9e35-352f8c04bcbe
Type
HUMAN OTC DRUG
Nonproprietary name
omeprazole
Dosage form
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route
ORAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
NDA209400
Marketing category
NDA
Marketing start
2018-08-20
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
Leader 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0381-1Leader Omeprazole1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING, D16
70000-0381-1Leader Omeprazole14 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D146
70000-0381-2Leader Omeprazole3 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D36
70000-0381-2Leader Omeprazole14 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D146

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0381LEADER OMEPRAZOLE (OMEPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER]6Current NDC, Legacy NDC, 4 package rows20241127_b2dd3c63-3875-4a9b-9b78-b5b3eba2aa1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2003656omeprazole 20 MG Delayed Release Disintegrating Oral TabletPSNb2dd3c63-3875-4a9b-9b78-b5b3eba2aa1a6
2003656omeprazole 20 MG Disintegrating Oral TabletSCDb2dd3c63-3875-4a9b-9b78-b5b3eba2aa1a6
2003656omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Disintegrating Oral TabletSYb2dd3c63-3875-4a9b-9b78-b5b3eba2aa1a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0381-17000003810114 BLISTER PACK in 1 CARTON (70000-0381-1) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK14 blister pack2018-08-200000-00-00NoNoCurrent
70000-0381-2700000381023 CARTON in 1 CARTON (70000-0381-2) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK3 carton2018-08-200000-00-00NoNoCurrent