FDA.reportPublic FDA data

Omeprazole

Product NDC
79903-305
11-digit product format
799030305
Labeler code
79903
Product ID
79903-305_cd2683cb-42a1-cb9f-6dd4-a1464ddb3afd
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Walmart Inc.
Application
ANDA207740
Marketing category
ANDA
Marketing start
2018-11-06
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
79903-305-14Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE143
79903-305-28Omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE23
79903-305-41Omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79903-305OMEPRAZOLE TABLET, DELAYED RELEASE [WALMART INC.]1Current NDC, 3 package rows20241009_5168ccd9-31b4-3a49-85b9-4f202cd99f6b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN5168ccd9-31b4-3a49-85b9-4f202cd99f6b3
402014omeprazole 20 MG Delayed Release Oral TabletSCD5168ccd9-31b4-3a49-85b9-4f202cd99f6b3
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY5168ccd9-31b4-3a49-85b9-4f202cd99f6b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79903-305-147990303051414 in 1 BOTTLEHistorical
79903-305-28799030305282 BOTTLE in 1 CARTON (79903-305-28) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (79903-305-14) 2 bottle2025-02-03NoNoHistorical
79903-305-41799030305411 BOTTLE in 1 CARTON (79903-305-41) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (79903-305-14) 1 bottle2026-03-28NoNoHistorical