FDA.reportPublic FDA data

Omeprazole

Product NDC
68788-6995
11-digit product format
687886995
Labeler code
68788
Product ID
68788-6995_8394cdff-fa1d-4f03-8c6d-7ce5d553451e
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
2017-10-27
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
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
68788-6995-1Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE1008
68788-6995-3Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE308
68788-6995-6Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE608
68788-6995-8Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE1208
68788-6995-9Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-6995-6EA - Each68788-6995c32005a4-a5ad-4e8b-b54c-43ec79cb07d112024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-6995OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 5 package rows20240726_fa0395a7-4353-4d64-9de8-d15857a7031c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSNfa0395a7-4353-4d64-9de8-d15857a7031c8
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDfa0395a7-4353-4d64-9de8-d15857a7031c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-6995-168788699501100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6995-1) 2017-10-270000-00-00NoNoCurrent
68788-6995-36878869950330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6995-3) 2017-10-270000-00-00NoNoCurrent
68788-6995-66878869950660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6995-6) 2017-10-270000-00-00NoNoCurrent
68788-6995-868788699508120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6995-8) 2017-10-270000-00-00NoNoCurrent
68788-6995-96878869950990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6995-9) 2017-10-270000-00-00NoNoCurrent