FDA.reportPublic FDA data

Omeprazole

Product NDC
70518-4177
11-digit product format
705184177
Labeler code
70518
Product ID
70518-4177_4b2d4aec-6f5a-2686-e063-6394a90a85f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078490
Marketing category
ANDA
Marketing start
2024-09-18
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
70518-4177-0Omeprazole30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE307
70518-4177-1Omeprazole90 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE907
70518-4177-2Omeprazole45 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE457
70518-4177-3Omeprazole60 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE607
70518-4177-4Omeprazole30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE307
70518-4177-5Omeprazole10 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4177OMEPRAZOLE CAPSULE, DELAYED RELEASE [REMEDYREPACK INC.]3Current NDC, 6 package rows20250501_63b3982a-b541-4b0d-99d4-93a673e57d46.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN63b3982a-b541-4b0d-99d4-93a673e57d467
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD63b3982a-b541-4b0d-99d4-93a673e57d467
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY63b3982a-b541-4b0d-99d4-93a673e57d467

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4177-07051841770030 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-4177-0) 2024-09-18NoNoHistorical
70518-4177-17051841770190 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-4177-1) 2025-02-21NoNoHistorical
70518-4177-27051841770245 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-4177-2) 2025-04-30NoNoHistorical
70518-4177-37051841770360 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-4177-3) 2025-06-13NoNoHistorical
70518-4177-47051841770430 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-4177-4) 2025-08-20NoNoHistorical
70518-4177-57051841770510 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-4177-5) 2026-02-18NoNoHistorical