FDA.reportPublic FDA data

Omeprazole

Product NDC
70518-2251
11-digit product format
705182251
Labeler code
70518
Product ID
70518-2251_4dd985de-3471-d963-e063-6294a90a827e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA091672
Marketing category
ANDA
Marketing start
2019-08-03
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui198051

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2251-0Omeprazole30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE3016
70518-2251-1Omeprazole14 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE1416
70518-2251-2Omeprazole90 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE9016
70518-2251-3Omeprazole100 in 1 BOXCAPSULE, DELAYED RELEASE10016
70518-2251-4Omeprazole1 in 1 POUCHCAPSULE, DELAYED RELEASE116
70518-2251-5Omeprazole30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE3016
70518-2251-6Omeprazole30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE3016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2251OMEPRAZOLE CAPSULE, DELAYED RELEASE [REMEDYREPACK INC.]9Current NDC, Legacy NDC, 7 package rows20250321_a19ce586-59b7-4c2e-9e8d-12e8f0f058e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNa19ce586-59b7-4c2e-9e8d-12e8f0f058e216
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDa19ce586-59b7-4c2e-9e8d-12e8f0f058e216
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYa19ce586-59b7-4c2e-9e8d-12e8f0f058e216

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2251-07051822510030 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-2251-0) 2019-08-030000-00-00NoNoCurrent
70518-2251-17051822510114 in 1 BOTTLE, PLASTICHistorical
70518-2251-27051822510290 in 1 BOTTLE, PLASTICHistorical
70518-2251-370518225103100 in 1 BOXHistorical
70518-2251-4705182251041 in 1 POUCHHistorical
70518-2251-57051822510530 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-2251-5) 2025-08-17NoNoHistorical
70518-2251-67051822510630 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-2251-6) 2026-03-20NoNoHistorical