FDA.reportPublic FDA data

Omeprazole

Product NDC
71610-880
11-digit product format
716100880
Labeler code
71610
Product ID
71610-880_31e58a0d-bc78-6a66-e063-6394a90acd34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA212977
Marketing category
ANDA
Marketing start
2024-12-27
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
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-880-00Omeprazole1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10002
71610-880-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE302
71610-880-53Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE602
71610-880-60Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE902
71610-880-80Omeprazole180 in 1 BOTTLECAPSULE, DELAYED RELEASE1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-880-30EA - Each71610-88082e46174-3df7-43ca-b2f5-0f5ff86c16b512025-06-13
71610-880-53EA - Each71610-8803693f082-c0f5-404d-8823-adf8ac5aaca612025-06-13
71610-880-60EA - Each71610-880cbac9f95-80f9-460e-b321-2f829bd4f62e12025-06-13
71610-880-80EA - Each71610-880b35c1bd5-1294-4b6e-8b4d-ca9dc52ba03c12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-880OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]2Current NDC, 5 package rows20250406_2e5d1b21-6b32-0c8d-e063-6294a90a8431.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSN2e5d1b21-6b32-0c8d-e063-6294a90a84312
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD2e5d1b21-6b32-0c8d-e063-6294a90a84312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-880-00716100880001000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-880-00) 2025-04-01NoNoHistorical
71610-880-307161008803030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-880-30) 2025-02-14NoNoHistorical
71610-880-537161008805360 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-880-53) 2025-02-14NoNoHistorical
71610-880-607161008806090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-880-60) 2025-02-14NoNoHistorical
71610-880-8071610088080180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-880-80) 2025-02-14NoNoHistorical