FDA.reportPublic FDA data

Omeprazole

Product NDC
68788-8771
11-digit product format
687888771
Labeler code
68788
Product ID
68788-8771_c3183e18-e844-49e6-8546-270232604cbf
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
2024-11-20
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
68788-8771-1Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE1002
68788-8771-3Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE302
68788-8771-6Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE602
68788-8771-8Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE1202
68788-8771-9Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8771-1EA - Each68788-8771d23f0fdf-cf2c-4a3a-a625-f2a7723c138612025-01-14
68788-8771-3EA - Each68788-8771b0603fb9-6d9d-4ae5-b06b-d8b7cb923efe12025-01-14
68788-8771-6EA - Each68788-8771a1443d8f-bf67-4a61-935b-a530411f7d6c12025-01-14
68788-8771-8EA - Each68788-8771e8733bb3-f4fd-4858-8d5c-cf1ef87b4cfa12025-01-14
68788-8771-9EA - Each68788-8771d59de492-44df-4fe9-8e1c-67b2bbda4d7a12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8771OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 5 package rows20241122_288bdd5e-a0ac-4c5c-abe0-93183a28dcdd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSN288bdd5e-a0ac-4c5c-abe0-93183a28dcdd2
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD288bdd5e-a0ac-4c5c-abe0-93183a28dcdd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8771-168788877101100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8771-1) 2024-11-20NoNoHistorical
68788-8771-36878887710330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8771-3) 2024-11-20NoNoHistorical
68788-8771-66878887710660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8771-6) 2024-11-20NoNoHistorical
68788-8771-868788877108120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8771-8) 2024-11-20NoNoHistorical
68788-8771-96878887710990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8771-9) 2024-11-20NoNoHistorical