FDA.reportPublic FDA data

Omeprazole

Product NDC
79903-377
11-digit product format
799030377
Labeler code
79903
Product ID
79903-377_525b880b-439d-436f-95a4-cb155ae85679
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
WALMART INC. (see also Equate)
Application
ANDA206582
Marketing category
ANDA
Marketing start
2025-04-30
Substance
OMEPRAZOLE MAGNESIUM
Active strength
20.6 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
OMEPRAZOLE MAGNESIUM20.6 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii426QFE7XLK
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
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79903-377-14Omeprazole14 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE143
79903-377-14Omeprazole1 in 1 BOXTABLET, DELAYED RELEASE13
79903-377-42Omeprazole14 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE143
79903-377-42Omeprazole3 in 1 BOXTABLET, DELAYED RELEASE33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79903-377OMEPRAZOLE TABLET, DELAYED RELEASE [WALMART INC. (SEE ALSO EQUATE)]2Current NDC, 4 package rows20250501_d3c1ba08-680d-4e39-875c-1f1d42ae787c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSNd3c1ba08-680d-4e39-875c-1f1d42ae787c3
402014omeprazole 20 MG Delayed Release Oral TabletSCDd3c1ba08-680d-4e39-875c-1f1d42ae787c3
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSYd3c1ba08-680d-4e39-875c-1f1d42ae787c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
79903-377-14799030377141 BOTTLE, PLASTIC in 1 BOX (79903-377-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2025-04-30NoNoCurrent
79903-377-42799030377423 BOTTLE, PLASTIC in 1 BOX (79903-377-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2025-04-30NoNoCurrent