FDA.reportPublic FDA data

Acid Reducer

Product NDC
53943-016
11-digit product format
539430016
Labeler code
53943
Product ID
53943-016_0029ee94-3c34-42fb-982f-9baefdfe0b3b
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
DISCOUNT DRUG MART
Application
ANDA206877
Marketing category
ANDA
Marketing start
2018-06-06
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
53943-016-05Acid Reducer14 in 1 BOTTLETABLET, DELAYED RELEASE146
53943-016-05Acid Reducer1 in 1 CARTONTABLET, DELAYED RELEASE16
53943-016-62Acid Reducer3 in 1 CARTONTABLET, DELAYED RELEASE36
53943-016-62Acid Reducer14 in 1 BOTTLETABLET, DELAYED RELEASE146

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-016ACID REDUCER (OMEPRAZOLE) TABLET, DELAYED RELEASE [DISCOUNT DRUG MART]6Current NDC, Legacy NDC, 4 package rows20231203_ff2c8446-9d8b-4300-b157-884b48e98bb7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSNff2c8446-9d8b-4300-b157-884b48e98bb76
402014omeprazole 20 MG Delayed Release Oral TabletSCDff2c8446-9d8b-4300-b157-884b48e98bb76
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSYff2c8446-9d8b-4300-b157-884b48e98bb76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53943-016-05539430016051 BOTTLE in 1 CARTON (53943-016-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2018-06-060000-00-00NoNoCurrent
53943-016-62539430016623 BOTTLE in 1 CARTON (53943-016-62) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2018-06-060000-00-00NoNoCurrent