FDA.reportPublic FDA data

leader omeprazole

Product NDC
70000-0723
11-digit product format
700000723
Labeler code
70000
Product ID
70000-0723_01e166d4-7ac5-421f-87d2-7b647631bf8d
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
NDA022032
Marketing category
NDA
Marketing start
2025-04-16
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
Rxcui402014

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
70000-0723-1leader omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE12
70000-0723-1leader omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE142
70000-0723-2leader omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE142
70000-0723-2leader omeprazole14 in 1 BLISTER PACKTABLET, DELAYED RELEASE142
70000-0723-3leader omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE142
70000-0723-3leader omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0723-1EA - Each70000-072396c6d77f-7da7-4e77-906c-4df3d90ddaea12026-03-17
70000-0723-2EA - Each70000-0723bd14515a-edca-410b-bc85-135506ec857312026-03-17
70000-0723-3EA - Each70000-0723fe2b8b29-ee36-4514-9b15-a1a72ece293912025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0723LEADER OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER]2Current NDC, 6 package rows20250418_19beab17-ca25-4be3-bada-20a2e9aa26b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN19beab17-ca25-4be3-bada-20a2e9aa26b52
402014omeprazole 20 MG Delayed Release Oral TabletSCD19beab17-ca25-4be3-bada-20a2e9aa26b52
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY19beab17-ca25-4be3-bada-20a2e9aa26b52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0723-1700000723011 BOTTLE in 1 CARTON (70000-0723-1) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2025-04-16NoNoHistorical
70000-0723-27000007230214 BLISTER PACK in 1 CARTON (70000-0723-2) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK14 blister pack2025-04-16NoNoHistorical
70000-0723-3700000723033 BOTTLE in 1 CARTON (70000-0723-3) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2025-04-16NoNoHistorical