FDA.reportPublic FDA data

Omeprazole

Product NDC
63187-828
11-digit product format
631870828
Labeler code
63187
Product ID
63187-828_b2a54105-0ef0-4196-a13d-72cf17d05af9
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
40 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
OMEPRAZOLE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui200329

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
63187-828-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE307
63187-828-60Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE607
63187-828-90Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-828-30EA - Each63187-8283e3ad42f-e18c-4ca2-8abb-9d842ed8a59e12017-06-15
63187-828-60EA - Each63187-8287bdae3f3-d60e-435b-94bc-94e2a6e880ea12025-05-14
63187-828-90EA - Each63187-8284e0481b5-7916-4b2c-a459-1cd9d270b4f812017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-828OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]7Current NDC, Legacy NDC, 3 package rows20240907_5ad413ed-a21b-4f8b-9322-8fbb813b14d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSN5ad413ed-a21b-4f8b-9322-8fbb813b14d37
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD5ad413ed-a21b-4f8b-9322-8fbb813b14d37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-828-146318708281414 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-828-14) 2016-10-010000-00-00NoNoCurrent
63187-828-306318708283030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-828-30) 2016-10-010000-00-00NoNoCurrent
63187-828-606318708286060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-828-60) 2017-04-030000-00-00NoNoCurrent
63187-828-7263187082872120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-828-72) 2016-10-010000-00-00NoNoCurrent
63187-828-7863187082878180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-828-78) 2017-04-030000-00-00NoNoCurrent
63187-828-906318708289090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-828-90) 2016-10-010000-00-00NoNoCurrent