FDA.reportPublic FDA data

omeprazole

Product NDC
30142-992
11-digit product format
301420992
Labeler code
30142
Product ID
30142-992_759b705a-526e-47e2-97f9-a78ab21a2c5d
Type
HUMAN OTC DRUG
Nonproprietary name
omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
THE KROGER COMPANY
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
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
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-992-14omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE143
30142-992-28omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-992OMEPRAZOLE TABLET, DELAYED RELEASE [THE KROGER COMPANY]3Current NDC, Legacy NDC, 2 package rows20230112_f55cedc7-e0bc-4d30-af52-bfa881f6adde.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSNf55cedc7-e0bc-4d30-af52-bfa881f6adde3
402014omeprazole 20 MG Delayed Release Oral TabletSCDf55cedc7-e0bc-4d30-af52-bfa881f6adde3
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSYf55cedc7-e0bc-4d30-af52-bfa881f6adde3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
30142-992-143014209921414 TABLET, DELAYED RELEASE in 1 BOTTLE (30142-992-14) 2020-07-150000-00-00NoNoCurrent
30142-992-28301420992282 TABLET, DELAYED RELEASE in 1 CARTON (30142-992-28) 2020-07-150000-00-00NoNoCurrent