Omeprazole

Product NDC
50436-3125
11-digit product format
504363125
Labeler code
50436
Product ID
50436-3125_04c1739e-c969-4866-90a1-ee7284cb5ef6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA075410
Marketing category
ANDA
Marketing start
2002-11-04
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
20 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-3125-1Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE606
50436-3125-2Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE306
50436-3125-3Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-3125OMEPRAZOLE CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES]6Legacy NDC, 3 package rows20170729_c22dfa61-ca2e-419c-9ff6-484023793699.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNc22dfa61-ca2e-419c-9ff6-4840237936996
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDc22dfa61-ca2e-419c-9ff6-4840237936996
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYc22dfa61-ca2e-419c-9ff6-4840237936996

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-3125-15043631250160 in 1 BOTTLEHistorical
50436-3125-25043631250230 in 1 BOTTLEHistorical
50436-3125-35043631250390 in 1 BOTTLEHistorical