FDA.reportPublic FDA data

Acid Reducer

Product NDC
58602-850
11-digit product format
586020850
Labeler code
58602
Product ID
58602-850_492b45bf-5734-4a64-8907-feaebadbb41a
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA206877
Marketing category
ANDA
Marketing start
2020-05-16
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
58602-850-05Acid Reducer1 in 1 CARTONTABLET, DELAYED RELEASE15
58602-850-05Acid Reducer14 in 1 BOTTLETABLET, DELAYED RELEASE145
58602-850-62Acid Reducer14 in 1 BOTTLETABLET, DELAYED RELEASE145
58602-850-62Acid Reducer3 in 1 CARTONTABLET, DELAYED RELEASE35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-850ACID REDUCER (OMEPRAZOLE) TABLET, DELAYED RELEASE [AUROHEALTH LLC]5Current NDC, Legacy NDC, 4 package rows20240618_287ceb12-e4d8-43c7-8cec-c4d23aa8fb12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN287ceb12-e4d8-43c7-8cec-c4d23aa8fb125
402014omeprazole 20 MG Delayed Release Oral TabletSCD287ceb12-e4d8-43c7-8cec-c4d23aa8fb125
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY287ceb12-e4d8-43c7-8cec-c4d23aa8fb125

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-850-05586020850051 BOTTLE in 1 CARTON (58602-850-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2020-05-160000-00-00NoNoCurrent
58602-850-62586020850623 BOTTLE in 1 CARTON (58602-850-62) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2020-05-160000-00-00NoNoCurrent