FDA.reportPublic FDA data

Omeprazole

Product NDC
68788-4104
11-digit product format
687884104
Labeler code
68788
Product ID
68788-4104_319d990e-161b-4c16-b026-f55c413c7e8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Preferred Phharmaceuticals Inc.
Application
ANDA203270
Marketing category
ANDA
Marketing start
2026-04-21
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
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
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-4104-1Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE1001
68788-4104-2Omeprazole20 in 1 BOTTLECAPSULE, DELAYED RELEASE201
68788-4104-3Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE301
68788-4104-4Omeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE141
68788-4104-6Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE601
68788-4104-8Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE1201
68788-4104-9Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN319d990e-161b-4c16-b026-f55c413c7e8f1
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD319d990e-161b-4c16-b026-f55c413c7e8f1
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY319d990e-161b-4c16-b026-f55c413c7e8f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-4104-168788410401100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-4104-1) 2026-04-21NoNoHistorical
68788-4104-26878841040220 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-4104-2) 2026-04-21NoNoHistorical
68788-4104-36878841040330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-4104-3) 2026-04-21NoNoHistorical
68788-4104-46878841040414 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-4104-4) 2026-04-21NoNoHistorical
68788-4104-66878841040660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-4104-6) 2026-04-21NoNoHistorical
68788-4104-868788410408120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-4104-8) 2026-04-21NoNoHistorical
68788-4104-96878841040990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-4104-9) 2026-04-21NoNoHistorical