FDA.reportPublic FDA data

Omeprazole

Product NDC
71610-280
11-digit product format
716100280
Labeler code
71610
Product ID
71610-280_3d7345e9-323c-c468-e063-6294a90a9aa6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA091672
Marketing category
ANDA
Marketing start
2014-10-31
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
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
71610-280-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE302
71610-280-53Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE602
71610-280-60Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE902
71610-280-80Omeprazole180 in 1 BOTTLECAPSULE, DELAYED RELEASE1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-280-30EA - Each71610-28081b1fa71-c191-4d2a-9df0-0516dc2eedb412025-10-14
71610-280-53EA - Each71610-280e6b77367-8613-45df-995d-fcc6077ef33d12025-10-14
71610-280-60EA - Each71610-2805674df68-0ec5-43a1-9aca-b9adfa7d051e12019-07-02
71610-280-80EA - Each71610-280b56ce7da-da88-4a94-845d-7ec5aaae673d12025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-280OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 4 package rows20190601_bab55f83-ba03-49a0-842a-19c9976b7fe8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSNbab55f83-ba03-49a0-842a-19c9976b7fe82
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDbab55f83-ba03-49a0-842a-19c9976b7fe82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-280-307161002803030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-280-30) 2025-08-27NoNoHistorical
71610-280-537161002805360 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-280-53) 2025-08-27NoNoHistorical
71610-280-607161002806090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-280-60) 2019-05-220000-00-00NoNoCurrent
71610-280-8071610028080180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-280-80) 2025-08-27NoNoHistorical