FDA.reportPublic FDA data

Omeprazole

Product NDC
68788-6881
11-digit product format
687886881
Labeler code
68788
Product ID
68788-6881_2ab7deaf-58ca-47ce-97ea-17adaf9d5d15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA091672
Marketing category
ANDA
Marketing start
2017-01-20
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
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
68788-6881-1Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE10010
68788-6881-2Omeprazole20 in 1 BOTTLECAPSULE, DELAYED RELEASE2010
68788-6881-3Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3010
68788-6881-4Omeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE1410
68788-6881-6Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE6010
68788-6881-8Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE12010
68788-6881-9Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-6881-3EA - Each68788-6881c39d754f-7bf4-4570-b578-cc21fc0a87f912019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-6881OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]8Current NDC, Legacy NDC, 7 package rows20240726_aa8fc2ea-3942-453b-bc19-1e4b14ba6926.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNaa8fc2ea-3942-453b-bc19-1e4b14ba692610
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDaa8fc2ea-3942-453b-bc19-1e4b14ba692610
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYaa8fc2ea-3942-453b-bc19-1e4b14ba692610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-6881-168788688101100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6881-1) 2017-01-200000-00-00NoNoCurrent
68788-6881-26878868810220 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6881-2) 2017-01-200000-00-00NoNoCurrent
68788-6881-36878868810330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6881-3) 2017-01-200000-00-00NoNoCurrent
68788-6881-46878868810414 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6881-4) 2017-01-200000-00-00NoNoCurrent
68788-6881-66878868810660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6881-6) 2017-01-200000-00-00NoNoCurrent
68788-6881-868788688108120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6881-8) 2017-01-200000-00-00NoNoCurrent
68788-6881-96878868810990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6881-9) 2017-01-200000-00-00NoNoCurrent