FDA.reportPublic FDA data

Omeprazole

Product NDC
83324-011
11-digit product format
833240011
Labeler code
83324
Product ID
83324-011_164b1d0f-ad03-40dd-e063-6394a90a6771
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION, INC.
Application
ANDA211732
Marketing category
ANDA
Marketing start
2024-05-10
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-011-14Omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE12
83324-011-14Omeprazole14 in 1 CONTAINERTABLET, DELAYED RELEASE142
83324-011-42Omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE32
83324-011-42Omeprazole14 in 1 CONTAINERTABLET, DELAYED RELEASE142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-011OMEPRAZOLE TABLET, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION, INC.]2Current NDC, 4 package rows20240510_da09aac6-8fce-448b-98ba-1fc9bce42075.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSNda09aac6-8fce-448b-98ba-1fc9bce420752
402014omeprazole 20 MG Delayed Release Oral TabletSCDda09aac6-8fce-448b-98ba-1fc9bce420752
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSYda09aac6-8fce-448b-98ba-1fc9bce420752

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-011-14833240011141 CONTAINER in 1 CARTON (83324-011-14) / 14 TABLET, DELAYED RELEASE in 1 CONTAINER1 container2024-05-10NoNoHistorical
83324-011-42833240011423 CONTAINER in 1 CARTON (83324-011-42) / 14 TABLET, DELAYED RELEASE in 1 CONTAINER3 container2024-05-10NoNoHistorical