FDA.reportPublic FDA data

members mark omeprazole

Product NDC
68196-915
11-digit product format
681960915
Labeler code
68196
Product ID
68196-915_ec7763a5-521c-486b-8215-2d66c97c3977
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Sam's West Inc
Application
NDA022032
Marketing category
NDA
Marketing start
2008-02-25
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
members mark omeprazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui402014

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68196-915-01members mark omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE149
68196-915-01members mark omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE19
68196-915-03members mark omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE149
68196-915-03members mark omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE39
68196-915-55members mark omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE39
68196-915-55members mark omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE149
68196-915-74members mark omeprazole1 in 1 BLISTER PACKTABLET, DELAYED RELEASE19
68196-915-74members mark omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE149

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-915MEMBERS MARK OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAM'S WEST INC]9Current NDC, Legacy NDC, 8 package rows20240628_0edfa800-fb14-44dd-9c31-de930b864ef9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN0edfa800-fb14-44dd-9c31-de930b864ef99
402014omeprazole 20 MG Delayed Release Oral TabletSCD0edfa800-fb14-44dd-9c31-de930b864ef99
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY0edfa800-fb14-44dd-9c31-de930b864ef99

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68196-915-01681960915011 BOTTLE in 1 CARTON (68196-915-01) > 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2016-11-020000-00-00NoNoCurrent
68196-915-036819609150314 in 1 BOTTLEHistorical
68196-915-55681960915553 CARTON in 1 CARTON (68196-915-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK3 carton2008-02-250000-00-00NoNoCurrent
68196-915-74681960915741 in 1 BLISTER PACKHistorical