FDA.reportPublic FDA data

Omeprazole

Product NDC
71610-912
11-digit product format
716100912
Labeler code
71610
Product ID
71610-912_3dd6a23e-9d69-1ebb-e063-6394a90ab10d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078490
Marketing category
ANDA
Marketing start
2014-03-01
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
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
71610-912-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE302
71610-912-53Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE602
71610-912-60Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE902
71610-912-80Omeprazole180 in 1 BOTTLECAPSULE, DELAYED RELEASE1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-912-30EA - Each71610-9125e83ddf2-c828-42fc-998b-53059568a13312025-10-14
71610-912-53EA - Each71610-912034eca5d-7662-45e6-a2ea-3530cbd1be0a12025-10-14
71610-912-60EA - Each71610-91215797a64-c0d1-4327-b48f-c4d93386a2e112025-07-08
71610-912-80EA - Each71610-9122444bb3c-30f3-42f5-b078-48b38d5e393712025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN3724b8f7-52ff-a5f8-e063-6294a90acf202
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD3724b8f7-52ff-a5f8-e063-6294a90acf202
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY3724b8f7-52ff-a5f8-e063-6294a90acf202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-912-307161009123030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-912-30) 2025-09-02NoNoHistorical
71610-912-537161009125360 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-912-53) 2025-09-02NoNoHistorical
71610-912-607161009126090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-912-60) 2025-06-05NoNoHistorical
71610-912-8071610091280180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-912-80) 2025-09-02NoNoHistorical