FDA.reportPublic FDA data

Omeprazole

Product NDC
0615-8406
11-digit product format
006158406
Labeler code
0615
Product ID
0615-8406_559600be-5b2c-4035-94b1-79ea261fa6a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA212977
Marketing category
ANDA
Marketing start
2019-02-20
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
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
OMEPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui198051

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0615-8406-05Omeprazole15 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE1522
0615-8406-07Omeprazole7 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE722
0615-8406-14Omeprazole14 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE1422
0615-8406-28Omeprazole28 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE2822
0615-8406-30Omeprazole6 in 1 BOX, UNIT-DOSECAPSULE, DELAYED RELEASE622
0615-8406-30Omeprazole5 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE522
0615-8406-31Omeprazole31 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE3122
0615-8406-39Omeprazole30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE3022

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8406OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]22Current NDC, Legacy NDC, 8 package rows20250110_f226173f-4318-43e0-847a-8ea237e6b41d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNf226173f-4318-43e0-847a-8ea237e6b41d22
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDf226173f-4318-43e0-847a-8ea237e6b41d22
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYf226173f-4318-43e0-847a-8ea237e6b41d22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8406-050061584060515 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8406-05) 2021-10-040000-00-00NoNoCurrent
0615-8406-07006158406077 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8406-07) 2023-08-09NoNoCurrent
0615-8406-140061584061414 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8406-14) 2021-10-040000-00-00NoNoCurrent
0615-8406-280061584062828 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8406-28) 2024-05-10NoNoCurrent
0615-8406-30006158406306 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8406-30) / 5 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK6 blister pack2021-10-040000-00-00NoNoCurrent
0615-8406-310061584063131 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8406-31) 2021-10-040000-00-00NoNoCurrent
0615-8406-390061584063930 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8406-39) 2021-10-040000-00-00NoNoCurrent