FDA.reportPublic FDA data

Acid Reducer

Product NDC
57483-120
11-digit product format
574830120
Labeler code
57483
Product ID
57483-120_a8fbf112-5de0-42fc-801f-6f21a09b1976
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
INNOVUS PHARMACEUTICALS, INC.
Application
ANDA206877
Marketing category
ANDA
Marketing start
2023-05-25
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE MAGNESIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii426QFE7XLK

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
57483-120-42Acid Reducer3 in 1 CARTONTABLET, DELAYED RELEASE32
57483-120-42Acid Reducer14 in 1 BOTTLETABLET, DELAYED RELEASE142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57483-120ACID REDUCER (OMEPRAZOLE) TABLET, DELAYED RELEASE [INNOVUS PHARMACEUTICALS, INC.]2Current NDC, 2 package rows20240618_a4e92bd2-8f75-4acc-9b75-df8332bd4cc4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSNa4e92bd2-8f75-4acc-9b75-df8332bd4cc42
402014omeprazole 20 MG Delayed Release Oral TabletSCDa4e92bd2-8f75-4acc-9b75-df8332bd4cc42
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSYa4e92bd2-8f75-4acc-9b75-df8332bd4cc42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57483-120-14574830120141 BOTTLE in 1 CARTON (57483-120-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2026-06-040Current
57483-120-42574830120423 BOTTLE in 1 CARTON (57483-120-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2023-05-25NoNoCurrent