FDA.reportPublic FDA data

Acid Reducer

Product NDC
30142-077
11-digit product format
301420077
Labeler code
30142
Product ID
30142-077_f5f26771-fb6e-4fc5-8ad9-92c64a9d7b81
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
KROGER COMPANY
Application
ANDA206877
Marketing category
ANDA
Marketing start
2023-03-13
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
30142-077-01Acid Reducer14 in 1 BLISTER PACKTABLET, DELAYED RELEASE143
30142-077-01Acid Reducer1 in 1 CARTONTABLET, DELAYED RELEASE13
30142-077-05Acid Reducer1 in 1 CARTONTABLET, DELAYED RELEASE13
30142-077-05Acid Reducer14 in 1 BOTTLETABLET, DELAYED RELEASE143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-077ACID REDUCER (OMEPRAZOLE) TABLET, DELAYED RELEASE [KROGER COMPANY]3Current NDC, 4 package rows20240618_eb5d02a8-4112-2066-e053-2a95a90abba3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSNeb5d02a8-4112-2066-e053-2a95a90abba33
402014omeprazole 20 MG Delayed Release Oral TabletSCDeb5d02a8-4112-2066-e053-2a95a90abba33
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSYeb5d02a8-4112-2066-e053-2a95a90abba33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
30142-077-01301420077011 BLISTER PACK in 1 CARTON (30142-077-01) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2023-03-13NoNoCurrent
30142-077-05301420077051 BOTTLE in 1 CARTON (30142-077-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2023-03-13NoNoCurrent