FDA.reportPublic FDA data

omeprazole

Product NDC
42507-414
11-digit product format
425070414
Labeler code
42507
Product ID
42507-414_c7e11072-2333-4846-a37b-2b2c3a59a6d0
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
HyVee Inc
Application
NDA022032
Marketing category
NDA
Marketing start
2026-01-28
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42507-414-00omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE142
42507-414-01omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE12
42507-414-42omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE32

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSNcf9919e6-a839-4bad-a007-80d5bf6f81db2
402014omeprazole 20 MG Delayed Release Oral TabletSCDcf9919e6-a839-4bad-a007-80d5bf6f81db2
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSYcf9919e6-a839-4bad-a007-80d5bf6f81db2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42507-414-004250704140014 in 1 BOTTLEHistorical
42507-414-01425070414011 BOTTLE in 1 CARTON (42507-414-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (42507-414-00) 1 bottle2026-01-28NoNoCurrent
42507-414-42425070414423 BOTTLE in 1 CARTON (42507-414-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (42507-414-00) 3 bottle2026-01-28NoNoCurrent