Omeprazole Magnesium

Product NDC
21130-398
11-digit product format
211300398
Labeler code
21130
Product ID
21130-398_b77ad3b7-9344-a9f2-aa4a-a27a63a0502d
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Albertsons Companies
Application
ANDA078878
Marketing category
ANDA
Marketing start
2016-02-01
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
Omeprazole Magnesium
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-398OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [ALBERTSONS COMPANIES]5Current NDC, Legacy NDC20241027_302b1332-181b-834b-4154-d849cb3a1ef0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN302b1332-181b-834b-4154-d849cb3a1ef06
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD302b1332-181b-834b-4154-d849cb3a1ef06
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY302b1332-181b-834b-4154-d849cb3a1ef06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-398-33211300398333 BOTTLE in 1 CARTON (21130-398-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2016-02-010000-00-00NoNoCurrent
21130-398-52211300398521 BOTTLE in 1 CARTON (21130-398-52) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2016-02-010000-00-00NoNoCurrent