FDA.reportPublic FDA data

Acid Reducer

Product NDC
58602-729
11-digit product format
586020729
Labeler code
58602
Product ID
58602-729_81d45120-49d4-4de8-8477-79312e2c1d56
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Aurohealth LLC
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
58602-729-01Acid Reducer1 in 1 CARTONTABLET, DELAYED RELEASE111
58602-729-01Acid Reducer14 in 1 BLISTER PACKTABLET, DELAYED RELEASE1411
58602-729-02Acid Reducer14 in 1 BLISTER PACKTABLET, DELAYED RELEASE1411
58602-729-02Acid Reducer2 in 1 CARTONTABLET, DELAYED RELEASE211
58602-729-03Acid Reducer3 in 1 CARTONTABLET, DELAYED RELEASE311
58602-729-03Acid Reducer14 in 1 BLISTER PACKTABLET, DELAYED RELEASE1411
58602-729-05Acid Reducer1 in 1 CARTONTABLET, DELAYED RELEASE111
58602-729-05Acid Reducer14 in 1 BOTTLETABLET, DELAYED RELEASE1411
58602-729-61Acid Reducer14 in 1 BOTTLETABLET, DELAYED RELEASE1411
58602-729-61Acid Reducer2 in 1 CARTONTABLET, DELAYED RELEASE211
58602-729-62Acid Reducer14 in 1 BOTTLETABLET, DELAYED RELEASE1411
58602-729-62Acid Reducer3 in 1 CARTONTABLET, DELAYED RELEASE311
58602-729-64Acid Reducer7 in 1 BLISTER PACKTABLET, DELAYED RELEASE711
58602-729-65Acid Reducer2 in 1 CARTONTABLET, DELAYED RELEASE211

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58602-729-61EA - Each58602-72908f1ab18-b9c4-41c7-a21b-87b5536e0d5e12024-04-05
58602-729-62EA - Each58602-7294fda5a3c-b0bf-4df0-9fd9-4b7f41beafa812024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-729ACID REDUCER (OMEPRAZOLE) TABLET, DELAYED RELEASE [AUROHEALTH LLC]11Current NDC, Legacy NDC, 14 package rows20240618_fde12bf8-3e3b-4813-a8c4-4385e7de8204.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSNfde12bf8-3e3b-4813-a8c4-4385e7de820411
402014omeprazole 20 MG Delayed Release Oral TabletSCDfde12bf8-3e3b-4813-a8c4-4385e7de820411
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSYfde12bf8-3e3b-4813-a8c4-4385e7de820411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-729-01586020729011 BLISTER PACK in 1 CARTON (58602-729-01) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2018-06-060000-00-00NoNoCurrent
58602-729-02586020729022 BLISTER PACK in 1 CARTON (58602-729-02) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 blister pack2018-06-060000-00-00NoNoCurrent
58602-729-03586020729033 BLISTER PACK in 1 CARTON (58602-729-03) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK3 blister pack2018-06-060000-00-00NoNoCurrent
58602-729-05586020729051 BOTTLE in 1 CARTON (58602-729-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2018-06-060000-00-00NoNoCurrent
58602-729-61586020729612 BOTTLE in 1 CARTON (58602-729-61) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE2 bottle2018-06-060000-00-00NoNoCurrent
58602-729-62586020729623 BOTTLE in 1 CARTON (58602-729-62) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2018-06-060000-00-00NoNoCurrent
58602-729-64586020729647 in 1 BLISTER PACKHistorical
58602-729-65586020729652 BLISTER PACK in 1 CARTON (58602-729-65) / 7 TABLET, DELAYED RELEASE in 1 BLISTER PACK (58602-729-64) 2 blister pack2018-06-060000-00-00NoNoCurrent