FDA.reportPublic FDA data

omeprazole

Product NDC
0363-6101
11-digit product format
003636101
Labeler code
0363
Product ID
0363-6101_ef7892f0-4389-4c7a-bc74-dabebce4b128
Type
HUMAN OTC DRUG
Nonproprietary name
omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Walgreen Company
Application
NDA022032
Marketing category
NDA
Marketing start
2023-03-09
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
0363-6101-01omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE142
0363-6101-03omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-6101OMEPRAZOLE TABLET, DELAYED RELEASE [WALGREEN COMPANY]2Current NDC, 2 package rows20230329_87cee50d-4c1e-473d-9d70-b1622f84aee1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN87cee50d-4c1e-473d-9d70-b1622f84aee12
402014omeprazole 20 MG Delayed Release Oral TabletSCD87cee50d-4c1e-473d-9d70-b1622f84aee12
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY87cee50d-4c1e-473d-9d70-b1622f84aee12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-6101-010036361010114 in 1 BOTTLEHistorical
0363-6101-03003636101033 BOTTLE in 1 CARTON (0363-6101-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (0363-6101-01) 3 bottle2023-03-09NoNoCurrent