FDA.reportPublic FDA data

equate omeprazole

Product NDC
79903-112
11-digit product format
799030112
Labeler code
79903
Product ID
79903-112_7b73e714-95e4-4f9f-a94c-78d214980106
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
WALMART INC.
Application
ANDA216096
Marketing category
ANDA
Marketing start
2022-11-30
Substance
OMEPRAZOLE MAGNESIUM
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
equate omeprazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE MAGNESIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii426QFE7XLK
Rxcui198051

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
79903-112-14equate omeprazole1 in 1 CARTONCAPSULE, DELAYED RELEASE13
79903-112-14equate omeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
79903-112-28equate omeprazole2 in 1 CARTONCAPSULE, DELAYED RELEASE23
79903-112-28equate omeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
79903-112-42equate omeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
79903-112-42equate omeprazole3 in 1 CARTONCAPSULE, DELAYED RELEASE33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79903-112EQUATE OMEPRAZOLE (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [WALMART INC.]3Current NDC, Legacy NDC, 6 package rows20250403_6790b6c8-c258-4dfb-a400-25dc2812971f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN6790b6c8-c258-4dfb-a400-25dc2812971f3
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD6790b6c8-c258-4dfb-a400-25dc2812971f3
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY6790b6c8-c258-4dfb-a400-25dc2812971f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79903-112-14799030112141 BOTTLE in 1 CARTON (79903-112-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2022-11-300000-00-00NoNoCurrent
79903-112-28799030112282 BOTTLE in 1 CARTON (79903-112-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2022-11-300000-00-00NoNoCurrent
79903-112-42799030112423 BOTTLE in 1 CARTON (79903-112-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2022-11-300000-00-00NoNoCurrent