Omeprazole

Product NDC
50090-4595
11-digit product format
500904595
Labeler code
50090
Product ID
50090-4595_ea5bbded-0930-4968-b525-754cfee700f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
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
2021-12-31
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
50090-4595-0Omeprazole32 in 1 CARTONCAPSULE, DELAYED RELEASE321
50090-4595-0Omeprazole1 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4595OMEPRAZOLE CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20200516_809a9c1b-5f8b-42a0-b1a4-9369e338bdc2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN809a9c1b-5f8b-42a0-b1a4-9369e338bdc21
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD809a9c1b-5f8b-42a0-b1a4-9369e338bdc21
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY809a9c1b-5f8b-42a0-b1a4-9369e338bdc21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4595-05009045950032 BLISTER PACK in 1 CARTON (50090-4595-0) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK32 blister pack2019-10-100000-00-00NoNoCurrent