FDA.reportPublic FDA data

omeprazole

Product NDC
0363-1819
11-digit product format
003631819
Labeler code
0363
Product ID
0363-1819_d56182bb-d424-4890-93c6-bca29194af8c
Type
HUMAN OTC DRUG
Nonproprietary name
omeprazole
Dosage form
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route
ORAL
Labeler
Walgreen Company
Application
NDA209400
Marketing category
NDA
Marketing start
2018-03-01
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
Rxcui2003656

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-1819-55omeprazole14 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D145
0363-1819-55omeprazole3 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D35
0363-1819-74omeprazole1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING, D15
0363-1819-74omeprazole14 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D145

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-1819-55EA - Each0363-181913e6c091-df33-49c9-b48b-c1a07c1793e912022-06-06
0363-1819-74EA - Each0363-1819def6f63b-60e6-42c2-8197-af5753ebd10512022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1819OMEPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [WALGREEN COMPANY]5Current NDC, Legacy NDC, 4 package rows20250125_064f048c-eddd-4370-9ee4-706f9f00c8d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2003656omeprazole 20 MG Delayed Release Disintegrating Oral TabletPSN064f048c-eddd-4370-9ee4-706f9f00c8d25
2003656omeprazole 20 MG Disintegrating Oral TabletSCD064f048c-eddd-4370-9ee4-706f9f00c8d25
2003656omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Disintegrating Oral TabletSY064f048c-eddd-4370-9ee4-706f9f00c8d25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-1819-55003631819553 CARTON in 1 CARTON (0363-1819-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK3 carton2018-03-010000-00-00NoNoCurrent
0363-1819-740036318197414 BLISTER PACK in 1 CARTON (0363-1819-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK14 blister pack2018-03-060000-00-00NoNoCurrent