FDA.reportPublic FDA data

Omeprazole

Product NDC
72162-2388
11-digit product format
721622388
Labeler code
72162
Product ID
72162-2388_014f4683-5caa-4eac-95ca-54ac52ac7423
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203270
Marketing category
ANDA
Marketing start
2015-08-19
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
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
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
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
72162-2388-0Omeprazole1000 in 1 BOTTLECAPSULE, DELAYED RELEASE1000102
72162-2388-2Omeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE14102
72162-2388-3Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE30102
72162-2388-5Omeprazole500 in 1 BOTTLECAPSULE, DELAYED RELEASE500102
72162-2388-6Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE60102
72162-2388-9Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE90102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2388-0EA - Each72162-2388aa8144f5-97bb-48ef-af54-7b270d31e33112024-10-04
72162-2388-2EA - Each72162-2388a7def8a5-4438-4e53-ac01-1e01d74e457112024-12-10
72162-2388-3EA - Each72162-23888351a342-831d-49a9-99af-6742909e49aa12024-12-10
72162-2388-5EA - Each72162-238851d7b2de-9d8f-494f-bd2c-12abe07f9a0212025-10-14
72162-2388-6EA - Each72162-23884f1e6e19-6e4d-4249-b633-f6ad6667b81c12024-12-10
72162-2388-9EA - Each72162-2388aeab80bc-f04c-49fc-b189-b526f748574612024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2388OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]101Current NDC, 6 package rows20241020_40b4e1b6-f64d-44d5-bfc2-0cb8f78d9e67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSN40b4e1b6-f64d-44d5-bfc2-0cb8f78d9e67102
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD40b4e1b6-f64d-44d5-bfc2-0cb8f78d9e67102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2388-0721622388001000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72162-2388-0) 2024-08-28NoNoHistorical
72162-2388-27216223880214 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72162-2388-2) 2024-08-28NoNoHistorical
72162-2388-37216223880330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72162-2388-3) 2024-08-28NoNoHistorical
72162-2388-572162238805500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72162-2388-5) 2024-08-28NoNoHistorical
72162-2388-67216223880660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72162-2388-6) 2024-08-28NoNoHistorical
72162-2388-97216223880990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72162-2388-9) 2024-08-28NoNoHistorical