FDA.reportPublic FDA data

omeprazole

Product NDC
72559-014
11-digit product format
725590014
Labeler code
72559
Product ID
72559-014_4d29deee-4362-9457-e063-6394a90a87eb
Type
HUMAN OTC DRUG
Nonproprietary name
omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Little Pharma, Inc.
Application
ANDA207891
Marketing category
ANDA
Marketing start
2020-07-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
omeprazole
Listing expiration
2027-12-31

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
72559-014-06omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE146
72559-014-06omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE36
72559-014-07omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE16
72559-014-07omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE146
72559-014-09omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE36
72559-014-09omeprazole3 in 1 PACKAGE, COMBINATIONTABLET, DELAYED RELEASE36
72559-014-36omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE36
72559-014-36omeprazole4 in 1 PACKAGE, COMBINATIONTABLET, DELAYED RELEASE46

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72559-014OMEPRAZOLE TABLET, DELAYED RELEASE [LITTLE PHARMA, INC.]5Current NDC, Legacy NDC, 8 package rows20240621_d4f86bbe-fe4d-41e2-96cc-4b4bbe2f1f7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSNd4f86bbe-fe4d-41e2-96cc-4b4bbe2f1f7f6
402014omeprazole 20 MG Delayed Release Oral TabletSCDd4f86bbe-fe4d-41e2-96cc-4b4bbe2f1f7f6
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSYd4f86bbe-fe4d-41e2-96cc-4b4bbe2f1f7f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72559-014-06725590014063 BOTTLE in 1 CARTON (72559-014-06) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2020-07-150000-00-00NoNoCurrent
72559-014-07725590014071 BOTTLE in 1 CARTON (72559-014-07) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2020-07-150000-00-00NoNoCurrent
72559-014-09725590014093 CARTON in 1 PACKAGE, COMBINATION (72559-014-09) / 3 BOTTLE in 1 CARTON / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 carton2026-03-31NoNoCurrent
72559-014-36725590014364 CARTON in 1 PACKAGE, COMBINATION (72559-014-36) / 3 BOTTLE in 1 CARTON / 14 TABLET, DELAYED RELEASE in 1 BOTTLE4 carton2024-06-18NoNoCurrent