FDA.reportPublic FDA data

Omeprazole

Product NDC
71610-942
11-digit product format
716100942
Labeler code
71610
Product ID
71610-942_3d6e0964-137d-df11-e063-6394a90a78f6
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
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
71610-942-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE301
71610-942-53Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE601
71610-942-60Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE901
71610-942-80Omeprazole180 in 1 BOTTLECAPSULE, DELAYED RELEASE1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-942-30EA - Each71610-942ab42ea56-6cc7-43a6-8bf0-43a74c0710a712025-10-14
71610-942-53EA - Each71610-942b5afa0bd-d4e6-468c-a541-9cbc89765a1412025-10-14
71610-942-60EA - Each71610-9428b8984aa-89be-4072-abe8-0749e51b63a512025-10-14
71610-942-80EA - Each71610-942259a46cd-5378-4b3e-950b-1b9b0e098c9812025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN3d6e07d1-38b1-f2ab-e063-6294a90a34ac1
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD3d6e07d1-38b1-f2ab-e063-6294a90a34ac1
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY3d6e07d1-38b1-f2ab-e063-6294a90a34ac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-942-307161009423030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-942-30) 2025-08-26NoNoHistorical
71610-942-537161009425360 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-942-53) 2025-08-26NoNoHistorical
71610-942-607161009426090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-942-60) 2025-08-26NoNoHistorical
71610-942-8071610094280180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-942-80) 2025-08-26NoNoHistorical