FDA.reportPublic FDA data

Omeprazole

Product NDC
80425-0415
11-digit product format
804250415
Labeler code
80425
Product ID
80425-0415_1d4ed9f8-bfc9-db89-e063-6394a90ae645
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA075576
Marketing category
ANDA
Marketing start
2024-07-15
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
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
80425-0415-1Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE301
80425-0415-2Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE601
80425-0415-3Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE901
80425-0415-4Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0415-1EA - Each80425-041577493244-f9f8-49a5-8eb2-f380e4e1387612024-08-12
80425-0415-2EA - Each80425-04156fa946d9-5fd2-4ca1-bbb7-3c8d2eb75a3c12024-08-12
80425-0415-3EA - Each80425-041562fe901b-c2bf-47da-85a2-f8c1ccc179fc12024-08-12
80425-0415-4EA - Each80425-041558af66ec-55bf-4cd7-aab8-e595c8ec753a12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0415OMEPRAZOLE CAPSULE, DELAYED RELEASE [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 4 package rows20240716_1d4ecc1e-5180-f75e-e063-6394a90a51a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN1d4ecc1e-5180-f75e-e063-6394a90a51a61
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD1d4ecc1e-5180-f75e-e063-6394a90a51a61
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY1d4ecc1e-5180-f75e-e063-6394a90a51a61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0415-18042504150130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0415-1) 2024-07-15NoNoHistorical
80425-0415-28042504150260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0415-2) 2024-07-15NoNoHistorical
80425-0415-38042504150390 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0415-3) 2024-07-15NoNoHistorical
80425-0415-480425041504120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0415-4) 2024-07-15NoNoHistorical