FDA.reportPublic FDA data

Omeprazole

Product NDC
55681-306
11-digit product format
556810306
Labeler code
55681
Product ID
55681-306_c9a11bc6-0680-4030-871e-599417fccf57
Type
HUMAN OTC DRUG
Nonproprietary name
OMEPRAZOLE
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Twin Med LLC
Application
ANDA207891
Marketing category
ANDA
Marketing start
2022-04-14
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
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55681-306-14Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE142
55681-306-14Omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE12
55681-306-42Omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE32
55681-306-42Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55681-306OMEPRAZOLE TABLET, DELAYED RELEASE [TWIN MED LLC]2Current NDC, Legacy NDC, 4 package rows20230112_346141b5-b49d-489a-84eb-18df8b940460.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN346141b5-b49d-489a-84eb-18df8b9404602
402014omeprazole 20 MG Delayed Release Oral TabletSCD346141b5-b49d-489a-84eb-18df8b9404602
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY346141b5-b49d-489a-84eb-18df8b9404602

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55681-306-14556810306141 BOTTLE in 1 CARTON (55681-306-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2022-04-140000-00-00NoNoCurrent
55681-306-42556810306423 BOTTLE in 1 CARTON (55681-306-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2022-04-140000-00-00NoNoCurrent