FDA.reportPublic FDA data

good sense omeprazole delayed release

Product NDC
0113-1803
11-digit product format
001131803
Labeler code
0113
Product ID
0113-1803_bffe358a-cc5a-4ff6-9a04-b0fbca4444e7
Type
HUMAN OTC DRUG
Nonproprietary name
omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
L. Perrigo Company
Application
NDA022032
Marketing category
NDA
Marketing start
2021-12-21
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
good sense omeprazole delayed release
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
0113-1803-01good sense omeprazole delayed release14 in 1 BOTTLETABLET, DELAYED RELEASE142
0113-1803-03good sense omeprazole delayed release3 in 1 CARTONTABLET, DELAYED RELEASE32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-1803GOOD SENSE OMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]2Current NDC, Legacy NDC, 2 package rows20240718_38082e59-c509-4be5-b29c-33a97565df1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN38082e59-c509-4be5-b29c-33a97565df1c2
402014omeprazole 20 MG Delayed Release Oral TabletSCD38082e59-c509-4be5-b29c-33a97565df1c2
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY38082e59-c509-4be5-b29c-33a97565df1c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-1803-010011318030114 in 1 BOTTLEHistorical
0113-1803-03001131803033 BOTTLE in 1 CARTON (0113-1803-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (0113-1803-01) 3 bottle2021-12-210000-00-00NoNoCurrent