FDA.reportPublic FDA data

Omeprazole

Product NDC
85509-1644
11-digit product format
855091644
Labeler code
85509
Product ID
85509-1644_3b19d244-3cd1-0813-e063-6394a90ac153
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
PHOENIX RX LLC
Application
ANDA078490
Marketing category
ANDA
Marketing start
2025-03-06
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
85509-1644-1Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE1201
85509-1644-3Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE301
85509-1644-6Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE601
85509-1644-9Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85509-1644-1EA - Each85509-16449e96706f-8927-419c-a0c6-d7408e4cd4cc12025-09-12
85509-1644-3EA - Each85509-1644b2e11bc7-ead9-40e8-ab83-75538d95d25912025-09-12
85509-1644-6EA - Each85509-164454013228-34f5-4ca3-b9af-f532fc6d54df12025-09-12
85509-1644-9EA - Each85509-1644245fc43b-8af5-4466-a2aa-e6007056b54712025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN3b19d724-821b-61dc-e063-6294a90aa4d31
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD3b19d724-821b-61dc-e063-6294a90aa4d31
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY3b19d724-821b-61dc-e063-6294a90aa4d31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85509-1644-185509164401120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85509-1644-1) 2025-07-29NoNoHistorical
85509-1644-38550916440330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85509-1644-3) 2025-07-29NoNoHistorical
85509-1644-68550916440660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85509-1644-6) 2025-07-29NoNoHistorical
85509-1644-98550916440990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85509-1644-9) 2025-07-29NoNoHistorical