FDA.reportPublic FDA data

Omeprazole

Product NDC
63187-820
11-digit product format
631870820
Labeler code
63187
Product ID
63187-820_8d62caf4-32be-4a2c-be08-c70a967ef307
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
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
63187-820-06Omeprazole6 in 1 BOTTLECAPSULE, DELAYED RELEASE67
63187-820-14Omeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE147
63187-820-20Omeprazole20 in 1 BOTTLECAPSULE, DELAYED RELEASE207
63187-820-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE307
63187-820-60Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE607
63187-820-72Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE1207
63187-820-78Omeprazole180 in 1 BOTTLECAPSULE, DELAYED RELEASE1807
63187-820-90Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-820-06EA - Each63187-8209154a522-aebb-4859-a2e6-2ebc1c4848f312019-11-12
63187-820-14EA - Each63187-820591f74c8-9b95-4692-883b-f936d0a6056812017-04-05
63187-820-30EA - Each63187-8201ef1dc34-4948-49a9-bd14-9ae7000aebfd12017-04-05
63187-820-60EA - Each63187-820d446b293-7971-41b9-a5b6-79d3da64e90312018-10-11
63187-820-78EA - Each63187-820960080a7-6ec4-4af2-a51c-8e8fbfaa574c12017-07-07
63187-820-90EA - Each63187-8200e8b01e5-aaa5-48cb-87f3-726bc57abebb12017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-820OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]7Current NDC, Legacy NDC, 8 package rows20220426_2d99b4fd-49b3-403d-96a4-0cceda85a95c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN2d99b4fd-49b3-403d-96a4-0cceda85a95c7
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD2d99b4fd-49b3-403d-96a4-0cceda85a95c7
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY2d99b4fd-49b3-403d-96a4-0cceda85a95c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-820-06631870820066 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-820-06) 2019-09-010000-00-00NoNoCurrent
63187-820-146318708201414 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-820-14) 2017-03-010000-00-00NoNoCurrent
63187-820-206318708202020 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-820-20) 2017-03-010000-00-00NoNoCurrent
63187-820-306318708203030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-820-30) 2017-03-010000-00-00NoNoCurrent
63187-820-606318708206060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-820-60) 2017-03-010000-00-00NoNoCurrent
63187-820-7263187082072120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-820-72) 2017-03-010000-00-00NoNoCurrent
63187-820-7863187082078180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-820-78) 2017-03-010000-00-00NoNoCurrent
63187-820-906318708209090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-820-90) 2017-03-010000-00-00NoNoCurrent