FDA.reportPublic FDA data

Omeprazole

Product NDC
16714-634
11-digit product format
167140634
Labeler code
16714
Product ID
16714-634_fe36a9a7-13d0-f4f1-1e31-b35cf651b79d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA078490
Marketing category
ANDA
Marketing start
2022-06-03
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, 199119, 200329

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
16714-634-01Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE306
16714-634-02Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE1006
16714-634-03Omeprazole1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-634OMEPRAZOLE CAPSULE, DELAYED RELEASE [NORTHSTAR RX LLC]5Current NDC, Legacy NDC, 3 package rows20231006_40a75dc7-49b7-5c9d-6c5f-d4682ec6922e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199119omeprazole 10 MG Delayed Release Oral CapsulePSN40a75dc7-49b7-5c9d-6c5f-d4682ec6922e6
198051omeprazole 20 MG Delayed Release Oral CapsulePSN40a75dc7-49b7-5c9d-6c5f-d4682ec6922e6
200329omeprazole 40 MG Delayed Release Oral CapsulePSN40a75dc7-49b7-5c9d-6c5f-d4682ec6922e6
199119omeprazole 10 MG Delayed Release Oral CapsuleSCD40a75dc7-49b7-5c9d-6c5f-d4682ec6922e6
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD40a75dc7-49b7-5c9d-6c5f-d4682ec6922e6
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD40a75dc7-49b7-5c9d-6c5f-d4682ec6922e6
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSY40a75dc7-49b7-5c9d-6c5f-d4682ec6922e6
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY40a75dc7-49b7-5c9d-6c5f-d4682ec6922e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-634-011671406340130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-634-01) 2022-06-030000-00-00NoNoCurrent
16714-634-0216714063402100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-634-02) 2022-06-030000-00-00NoNoCurrent
16714-634-03167140634031000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-634-03) 2022-06-030000-00-00NoNoCurrent