FDA.reportPublic FDA data

rugby omeprazole

Product NDC
0536-1448
11-digit product format
005361448
Labeler code
0536
Product ID
0536-1448_bc786388-cb4d-4210-9124-39a4bcbb7d38
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Rugby Laboratories
Application
NDA022032
Marketing category
NDA
Marketing start
2025-04-15
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
rugby 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
0536-1448-13rugby omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE32
0536-1448-13rugby omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE142
0536-1448-88rugby omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE142
0536-1448-88rugby omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1448-13EA - Each0536-1448d61c3a7f-80ec-4c19-9ff7-2035cf15026712026-03-17
0536-1448-88EA - Each0536-1448c5475b88-8d9e-44d1-9546-da33c6c4809d12025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1448RUGBY OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [RUGBY LABORATORIES]2Current NDC, 4 package rows20250418_61952807-f38d-4e7a-8646-a8ec85d7fb37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN61952807-f38d-4e7a-8646-a8ec85d7fb372
402014omeprazole 20 MG Delayed Release Oral TabletSCD61952807-f38d-4e7a-8646-a8ec85d7fb372
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY61952807-f38d-4e7a-8646-a8ec85d7fb372

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0536-1448-13005361448133 BOTTLE in 1 CARTON (0536-1448-13) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2025-04-15NoNoHistorical
0536-1448-88005361448881 BOTTLE in 1 CARTON (0536-1448-88) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2025-04-15NoNoHistorical