Omeprazole Magnesium

Product NDC
69842-027
11-digit product format
698420027
Labeler code
69842
Product ID
69842-027_337e6afa-c24a-94b7-5b3f-2a8d477ac2a9
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
CVS Health Corp.
Application
ANDA078878
Marketing category
ANDA
Marketing start
2011-11-01
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
69842-027OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [CVS HEALTH CORP.]6Current NDC, Legacy NDC20240816_3bbfa87d-f8b7-19bd-9f12-39cba31ae0b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN3bbfa87d-f8b7-19bd-9f12-39cba31ae0b37
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD3bbfa87d-f8b7-19bd-9f12-39cba31ae0b37
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY3bbfa87d-f8b7-19bd-9f12-39cba31ae0b37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-027-01698420027013 BOTTLE in 1 CARTON (69842-027-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2015-10-010000-00-00NoNoCurrent
69842-027-14698420027141 BOTTLE in 1 CARTON (69842-027-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2011-11-010000-00-00NoNoCurrent
69842-027-28698420027282 BOTTLE in 1 CARTON (69842-027-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2011-11-010000-00-00NoNoCurrent
69842-027-42698420027423 BOTTLE in 1 CARTON (69842-027-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2011-11-010000-00-00NoNoCurrent