FDA.reportPublic FDA data

Omeprazole

Product NDC
0615-8079
11-digit product format
006158079
Labeler code
0615
Product ID
0615-8079_0c6e0de8-3ef8-4745-9ce4-d52f7c28bde3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA091672
Marketing category
ANDA
Marketing start
2014-10-31
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole
Listing expiration
2026-12-31

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
0615-8079-05Omeprazole15 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE1516
0615-8079-07Omeprazole7 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE716
0615-8079-28Omeprazole28 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE2816
0615-8079-39Omeprazole30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE3016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8079OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]16Current NDC, Legacy NDC, 4 package rows20250119_d1e0c8fc-1f15-45a4-a80f-653a1dae5e56.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSNd1e0c8fc-1f15-45a4-a80f-653a1dae5e5616
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDd1e0c8fc-1f15-45a4-a80f-653a1dae5e5616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0615-8079-050061580790515 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8079-05) 2014-10-310000-00-00NoNoCurrent
0615-8079-07006158079077 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8079-07) 2018-11-020000-00-00NoNoCurrent
0615-8079-280061580792828 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8079-28) 2025-01-10NoNoCurrent
0615-8079-390061580793930 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8079-39) 2014-10-310000-00-00NoNoCurrent