Omeprazole

Product NDC
33261-441
11-digit product format
332610441
Labeler code
33261
Product ID
33261-441_69e110c7-961b-433f-ab96-cd1c4c739c78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA075576
Marketing category
ANDA
Marketing start
2009-01-21
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
40 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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
33261-441-30Omeprazole30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE301
33261-441-60Omeprazole60 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE601
33261-441-90Omeprazole90 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-441OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20140128_f30c4317-bb6a-452d-b1aa-78dbd09c3833.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSNf30c4317-bb6a-452d-b1aa-78dbd09c38331
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDf30c4317-bb6a-452d-b1aa-78dbd09c38331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-441-303326104413030 in 1 BOTTLE, PLASTICHistorical
33261-441-603326104416060 in 1 BOTTLE, PLASTICHistorical
33261-441-903326104419090 in 1 BOTTLE, PLASTICHistorical