FDA.reportPublic FDA data

Acid Reducer

Product NDC
69842-941
11-digit product format
698420941
Labeler code
69842
Product ID
69842-941_94a59c53-72bd-4d37-9ea9-c73f51ea1031
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
CVS Pharmacy, Inc.
Application
ANDA206877
Marketing category
ANDA
Marketing start
2020-09-23
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
Acid Reducer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE MAGNESIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii426QFE7XLK
Rxcui402014

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
69842-941-01Acid Reducer14 in 1 BLISTER PACKTABLET, DELAYED RELEASE145
69842-941-01Acid Reducer1 in 1 CARTONTABLET, DELAYED RELEASE15
69842-941-03Acid Reducer14 in 1 BLISTER PACKTABLET, DELAYED RELEASE145
69842-941-03Acid Reducer3 in 1 CARTONTABLET, DELAYED RELEASE35
69842-941-05Acid Reducer14 in 1 BOTTLETABLET, DELAYED RELEASE145
69842-941-05Acid Reducer1 in 1 CARTONTABLET, DELAYED RELEASE15
69842-941-61Acid Reducer14 in 1 BOTTLETABLET, DELAYED RELEASE145
69842-941-61Acid Reducer2 in 1 CARTONTABLET, DELAYED RELEASE25
69842-941-62Acid Reducer3 in 1 CARTONTABLET, DELAYED RELEASE35
69842-941-62Acid Reducer14 in 1 BOTTLETABLET, DELAYED RELEASE145

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-941ACID REDUCER (OMEPRAZOLE) TABLET, DELAYED RELEASE [CVS PHARMACY, INC.]5Current NDC, Legacy NDC, 10 package rows20240628_3349ee88-e53b-4586-8d28-20ecf8fcb1a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN3349ee88-e53b-4586-8d28-20ecf8fcb1a55
402014omeprazole 20 MG Delayed Release Oral TabletSCD3349ee88-e53b-4586-8d28-20ecf8fcb1a55
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY3349ee88-e53b-4586-8d28-20ecf8fcb1a55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-941-01698420941011 BLISTER PACK in 1 CARTON (69842-941-01) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2020-09-230000-00-00NoNoCurrent
69842-941-03698420941033 BLISTER PACK in 1 CARTON (69842-941-03) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK3 blister pack2020-09-230000-00-00NoNoCurrent
69842-941-05698420941051 BOTTLE in 1 CARTON (69842-941-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2020-09-230000-00-00NoNoCurrent
69842-941-61698420941612 BOTTLE in 1 CARTON (69842-941-61) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE2 bottle2020-09-230000-00-00NoNoCurrent
69842-941-62698420941623 BOTTLE in 1 CARTON (69842-941-62) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2020-09-230000-00-00NoNoCurrent