FDA.reportPublic FDA data

Omeprazole

Product NDC
72789-482
11-digit product format
727890482
Labeler code
72789
Product ID
72789-482_4de033d6-628d-0d46-e063-6294a90ad04f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078490
Marketing category
ANDA
Marketing start
2014-03-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole
Listing expiration
2027-12-31

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
72789-482-14Omeprazole14 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE1436
72789-482-30Omeprazole30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE3036
72789-482-60Omeprazole60 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE6036
72789-482-90Omeprazole90 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE9036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-482-14EA - Each72789-4821133f966-1dc9-4568-bdbf-22f68d8d061312025-06-13
72789-482-30EA - Each72789-4823a282ae8-5043-4c06-93d4-7d0ae0c80d1212025-05-14
72789-482-60EA - Each72789-48276cadecc-d113-4104-b8b6-8d238cc3eb0f12025-05-14
72789-482-90EA - Each72789-48262ee2036-b96e-4ae8-8f76-fc6e0dea9bdb12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-482OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]34Current NDC, 4 package rows20250509_96104ea6-c08f-40b5-83f5-d840b317f1fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN96104ea6-c08f-40b5-83f5-d840b317f1fd36
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD96104ea6-c08f-40b5-83f5-d840b317f1fd36
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY96104ea6-c08f-40b5-83f5-d840b317f1fd36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-482-147278904821414 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-482-14) 2025-05-07NoNoHistorical
72789-482-307278904823030 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-482-30) 2025-01-25NoNoHistorical
72789-482-607278904826060 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-482-60) 2025-03-20NoNoHistorical
72789-482-907278904829090 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-482-90) 2025-01-23NoNoHistorical