FDA.reportPublic FDA data

Omeprazole

Product NDC
16714-123
11-digit product format
167140123
Labeler code
16714
Product ID
16714-123_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
2019-10-25
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
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
16714-123-01Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE306
16714-123-02Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE1006
16714-123-03Omeprazole500 in 1 BOTTLECAPSULE, DELAYED RELEASE5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-123-01EA - Each16714-1231766dd81-b9c2-465a-b977-f6e197c87d0112020-02-13
16714-123-02EA - Each16714-123f0cb213d-4f0f-40ad-af1c-5389788bbc9212020-02-13
16714-123-03EA - Each16714-1230ebc12c4-2a88-4f16-8e82-c281a5c3d57f12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-123OMEPRAZOLE 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
200329omeprazole 40 MG Delayed Release Oral CapsulePSNb4cd8ed1-d9d3-5b57-e053-2995a90a9f3c7
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDb4cd8ed1-d9d3-5b57-e053-2995a90a9f3c7
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
200329omeprazole 40 MG Delayed Release Oral CapsulePSN8f13fd38-dc73-4072-bdc9-9474704a41213
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD8f13fd38-dc73-4072-bdc9-9474704a41213
200329omeprazole 40 MG Delayed Release Oral CapsulePSNe07af8c9-559c-5a93-e053-2a95a90a2c632
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDe07af8c9-559c-5a93-e053-2a95a90a2c632
200329omeprazole 40 MG Delayed Release Oral CapsulePSNa656a059-2b1a-44b3-85f8-af278032b54c1
200329omeprazole 40 MG Delayed Release Oral CapsulePSN40f66cac-bc23-43f9-9966-87cce458c9961
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDa656a059-2b1a-44b3-85f8-af278032b54c1
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD40f66cac-bc23-43f9-9966-87cce458c9961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-123-011671401230130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-123-01) 2019-10-250000-00-00NoNoCurrent
16714-123-0216714012302100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-123-02) 2019-10-250000-00-00NoNoCurrent
16714-123-0316714012303500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-123-03) 2019-10-250000-00-00NoNoCurrent