FDA.reportPublic FDA data

Omeprazole

Product NDC
85509-1396
11-digit product format
855091396
Labeler code
85509
Product ID
85509-1396_3a9b8b8b-2be6-df5a-e063-6394a90a6878
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
PHOENIX RX LLC
Application
ANDA091672
Marketing category
ANDA
Marketing start
2017-01-20
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
85509-1396-1Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE1201
85509-1396-2Omeprazole20 in 1 BOTTLECAPSULE, DELAYED RELEASE201
85509-1396-3Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE301
85509-1396-6Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE601
85509-1396-9Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85509-1396-1EA - Each85509-139611144db2-f42f-4b47-93b6-263cf13d5de012025-09-12
85509-1396-2EA - Each85509-139666beb49f-2af2-489c-9674-b48347d5c22612025-09-12
85509-1396-3EA - Each85509-1396e3431519-48d3-43bd-b10a-c17930055e5812025-09-12
85509-1396-6EA - Each85509-1396e3afc29a-af8f-4e80-a5a4-254bea2589ba12025-09-12
85509-1396-9EA - Each85509-139603a8cc1c-7442-4fee-b72f-3f4c07b31c3212025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN3a9baece-03be-6c77-e063-6394a90a70321
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD3a9baece-03be-6c77-e063-6394a90a70321
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY3a9baece-03be-6c77-e063-6394a90a70321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85509-1396-185509139601120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85509-1396-1) 2025-07-23NoNoHistorical
85509-1396-28550913960220 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85509-1396-2) 2025-07-23NoNoHistorical
85509-1396-38550913960330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85509-1396-3) 2025-07-23NoNoHistorical
85509-1396-68550913960660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85509-1396-6) 2025-07-23NoNoHistorical
85509-1396-98550913960990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85509-1396-9) 2025-07-23NoNoHistorical