FDA.reportPublic FDA data

OMEPRAZOLE

Product NDC
21130-783
11-digit product format
211300783
Labeler code
21130
Product ID
21130-783_0aed553e-3a3b-44a6-8dbf-99a56d2640a3
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Safeway
Application
ANDA216096
Marketing category
ANDA
Marketing start
2026-04-27
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
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
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
21130-783-01OMEPRAZOLE1 in 1 CARTONCAPSULE, DELAYED RELEASE13
21130-783-01OMEPRAZOLE14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
21130-783-03OMEPRAZOLE3 in 1 CARTONCAPSULE, DELAYED RELEASE33
21130-783-03OMEPRAZOLE14 in 1 BOTTLECAPSULE, DELAYED RELEASE143

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNb3ec4a44-5643-4438-b41b-e049464367193
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDb3ec4a44-5643-4438-b41b-e049464367193
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYb3ec4a44-5643-4438-b41b-e049464367193

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-783-01211300783011 BOTTLE in 1 CARTON (21130-783-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2026-05-180Current
21130-783-03211300783033 BOTTLE in 1 CARTON (21130-783-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2026-04-27NoNoCurrent