FDA.reportPublic FDA data

Omeprazole

Product NDC
70518-3278
11-digit product format
705183278
Labeler code
70518
Product ID
70518-3278_4ee02091-1fc3-bab3-e063-6294a90acbfa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA212977
Marketing category
ANDA
Marketing start
2021-11-29
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
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3278-0Omeprazole30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE3011
70518-3278-1Omeprazole30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE3011
70518-3278-2Omeprazole90 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE9011
70518-3278-3Omeprazole30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE3011
70518-3278-4Omeprazole60 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE6011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3278OMEPRAZOLE CAPSULE, DELAYED RELEASE [REMEDYREPACK INC.]9Current NDC, Legacy NDC, 5 package rows20241225_ded0df8b-1813-4595-ac2b-5499704bfd48.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNded0df8b-1813-4595-ac2b-5499704bfd4811
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDded0df8b-1813-4595-ac2b-5499704bfd4811
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYded0df8b-1813-4595-ac2b-5499704bfd4811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3278-07051832780030 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-3278-0) 2021-11-290000-00-00NoNoCurrent
70518-3278-17051832780130 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-3278-1) 2021-12-280000-00-00NoNoCurrent
70518-3278-27051832780290 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-3278-2) 2022-02-070000-00-00NoNoCurrent
70518-3278-37051832780330 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-3278-3) 2024-05-15NoNoHistorical
70518-3278-47051832780460 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-3278-4) 2024-05-16NoNoHistorical