FDA.reportPublic FDA data

omeprazole

Product NDC
57483-840
11-digit product format
574830840
Labeler code
57483
Product ID
57483-840_3fc301fe-e89b-488b-8437-c48b59cec420
Type
HUMAN OTC DRUG
Nonproprietary name
omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
INNOVUS PHARMACEUTICALS, INC.
Application
ANDA207891
Marketing category
ANDA
Marketing start
2020-08-10
Substance
OMEPRAZOLE
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
omeprazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
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
57483-840-01omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE142
57483-840-42omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57483-840OMEPRAZOLE TABLET, DELAYED RELEASE [INNOVUS PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20241116_7535a309-1a67-4f50-911b-7cf570322931.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN7535a309-1a67-4f50-911b-7cf5703229312
402014omeprazole 20 MG Delayed Release Oral TabletSCD7535a309-1a67-4f50-911b-7cf5703229312
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY7535a309-1a67-4f50-911b-7cf5703229312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57483-840-015748308400114 in 1 BOTTLEHistorical
57483-840-42574830840423 BOTTLE in 1 CARTON (57483-840-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (57483-840-01) 3 bottle2020-08-100000-00-00NoNoCurrent