FDA.reportPublic FDA data

Omeprazole

Product NDC
68788-8805
11-digit product format
687888805
Labeler code
68788
Product ID
68788-8805_a806da8c-5f84-454d-966c-da1c48710f80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078490
Marketing category
ANDA
Marketing start
2025-01-20
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
68788-8805-1Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE1001
68788-8805-2Omeprazole20 in 1 BOTTLECAPSULE, DELAYED RELEASE201
68788-8805-3Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE301
68788-8805-4Omeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE141
68788-8805-6Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE601
68788-8805-7Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE1201
68788-8805-9Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8805-1EA - Each68788-88050a030618-0584-4f45-bf77-ea67de4dca2512025-03-04
68788-8805-2EA - Each68788-880503ba9820-f28d-4008-a4e2-333a7e8059e512025-03-04
68788-8805-3EA - Each68788-8805728bcb74-2674-407b-be4e-9b1cc33a6d9812025-03-04
68788-8805-4EA - Each68788-8805e82ff863-8d61-47ee-9a41-6454b90d3c6412025-03-04
68788-8805-6EA - Each68788-88055efa514c-14f6-4b13-bcf3-a54af8e3e5ff12025-03-04
68788-8805-7EA - Each68788-88051cd22a2f-a8c9-4865-a4dd-699744c56f0512025-03-04
68788-8805-9EA - Each68788-880584cffbf5-87af-4398-9417-379b59d6d0bc12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8805OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 7 package rows20250122_a806da8c-5f84-454d-966c-da1c48710f80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNa806da8c-5f84-454d-966c-da1c48710f801
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDa806da8c-5f84-454d-966c-da1c48710f801
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYa806da8c-5f84-454d-966c-da1c48710f801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8805-168788880501100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8805-1) 2025-01-20NoNoHistorical
68788-8805-26878888050220 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8805-2) 2025-01-20NoNoHistorical
68788-8805-36878888050330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8805-3) 2025-01-20NoNoHistorical
68788-8805-46878888050414 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8805-4) 2025-01-20NoNoHistorical
68788-8805-66878888050660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8805-6) 2025-01-20NoNoHistorical
68788-8805-768788880507120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8805-7) 2025-01-20NoNoHistorical
68788-8805-96878888050990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8805-9) 2025-01-20NoNoHistorical