FDA.reportPublic FDA data

Omeprazole

Product NDC
69168-476
11-digit product format
691680476
Labeler code
69168
Product ID
69168-476_37309c28-8650-401e-9a39-6b52112e0baf
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Allegiant Health
Application
ANDA211732
Marketing category
ANDA
Marketing start
2025-03-21
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
69168-476-14Omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE12
69168-476-14Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE142
69168-476-15Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE142
69168-476-42Omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE32
69168-476-42Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE142
69168-476-61Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE142
69168-476-61Omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-476OMEPRAZOLE TABLET, DELAYED RELEASE [ALLEGIANT HEALTH]2Current NDC, 7 package rows20250327_3344c589-c4ac-4f2d-8d32-828db4e825a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN3344c589-c4ac-4f2d-8d32-828db4e825a62
402014omeprazole 20 MG Delayed Release Oral TabletSCD3344c589-c4ac-4f2d-8d32-828db4e825a62
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY3344c589-c4ac-4f2d-8d32-828db4e825a62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69168-476-14691680476141 BOTTLE in 1 CARTON (69168-476-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2025-03-21NoNoCurrent
69168-476-156916804761514 TABLET, DELAYED RELEASE in 1 BOTTLE (69168-476-15) 2025-03-21NoNoCurrent
69168-476-42691680476423 BOTTLE in 1 CARTON (69168-476-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2025-03-21NoNoCurrent
69168-476-61691680476611 BOTTLE in 1 CARTON (69168-476-61) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2025-03-21NoNoCurrent