FDA.reportPublic FDA data

Acid Reducer

Product NDC
70000-0521
11-digit product format
700000521
Labeler code
70000
Product ID
70000-0521_a54de89f-8710-4fc7-97c3-8607e5974263
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Cardinal Health
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
70000-0521-1Acid Reducer1 in 1 CARTONTABLET, DELAYED RELEASE16
70000-0521-1Acid Reducer14 in 1 BOTTLETABLET, DELAYED RELEASE146
70000-0521-2Acid Reducer1 in 1 CARTONTABLET, DELAYED RELEASE16
70000-0521-2Acid Reducer14 in 1 BLISTER PACKTABLET, DELAYED RELEASE146
70000-0521-3Acid Reducer14 in 1 BOTTLETABLET, DELAYED RELEASE146
70000-0521-3Acid Reducer2 in 1 CARTONTABLET, DELAYED RELEASE26
70000-0521-4Acid Reducer14 in 1 BOTTLETABLET, DELAYED RELEASE146
70000-0521-4Acid Reducer3 in 1 CARTONTABLET, DELAYED RELEASE36

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0521-1EA - Each70000-0521fddb8ef0-7fe1-4c49-b047-5f0273529b6e12020-05-08
70000-0521-2EA - Each70000-05217401da9e-e3e9-4318-8d0f-c54a505c075412021-05-05
70000-0521-3EA - Each70000-05218b52fc6f-b99d-42b7-80c5-6fd2ed028c6512021-05-05
70000-0521-4EA - Each70000-05210646685b-796e-4c1c-819e-019229056a4212021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0521ACID REDUCER (OMEPRAZOLE) TABLET, DELAYED RELEASE [CARDINAL HEALTH]6Current NDC, Legacy NDC, 8 package rows20240618_230e1aca-6644-4e6d-a6e1-9ba04cdcc8a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN230e1aca-6644-4e6d-a6e1-9ba04cdcc8a86
402014omeprazole 20 MG Delayed Release Oral TabletSCD230e1aca-6644-4e6d-a6e1-9ba04cdcc8a86
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY230e1aca-6644-4e6d-a6e1-9ba04cdcc8a86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0521-1700000521011 BOTTLE in 1 CARTON (70000-0521-1) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2018-06-060000-00-00NoNoCurrent
70000-0521-2700000521021 BLISTER PACK in 1 CARTON (70000-0521-2) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2020-10-210000-00-00NoNoCurrent
70000-0521-3700000521032 BOTTLE in 1 CARTON (70000-0521-3) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE2 bottle2020-10-210000-00-00NoNoCurrent
70000-0521-4700000521043 BOTTLE in 1 CARTON (70000-0521-4) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2020-10-210000-00-00NoNoCurrent