FDA.reportPublic FDA data

Omeprazole

Product NDC
70518-0199
11-digit product format
705180199
Labeler code
70518
Product ID
70518-0199_4cd8d34f-1629-4782-e063-6394a90a315e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA091672
Marketing category
ANDA
Marketing start
2017-02-06
Substance
OMEPRAZOLE
Active strength
40 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
OMEPRAZOLE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui200329

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
70518-0199-0Omeprazole90 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE9021
70518-0199-1Omeprazole30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE3021
70518-0199-2Omeprazole30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE3021
70518-0199-3Omeprazole14 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE1421
70518-0199-4Omeprazole30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE3021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0199OMEPRAZOLE CAPSULE, DELAYED RELEASE [REMEDYREPACK INC.]16Current NDC, Legacy NDC, 5 package rows20250424_d9b3918c-a66e-4277-8b8f-b7ece93fa7db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSNd9b3918c-a66e-4277-8b8f-b7ece93fa7db21
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDd9b3918c-a66e-4277-8b8f-b7ece93fa7db21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-0199-07051801990090 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-0199-0) 2017-02-060000-00-00NoNoCurrent
70518-0199-17051801990130 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-0199-1) 2017-03-020000-00-00NoNoCurrent
70518-0199-27051801990230 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-0199-2) 2022-06-060000-00-00NoNoCurrent
70518-0199-37051801990314 in 1 BOTTLE, PLASTICHistorical
70518-0199-47051801990430 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-0199-4) 2025-07-08NoNoCurrent