Omeprazole

Product NDC
45865-966
11-digit product format
458650966
Labeler code
45865
Product ID
45865-966_9aefefe6-9666-368b-e053-2995a90a0de7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA091672
Marketing category
ANDA
Marketing start
2014-10-31
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
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
45865-966-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-966OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20191231_9af00688-8cd1-35c5-e053-2995a90ab011.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSN9af00688-8cd1-35c5-e053-2995a90ab0111
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD9af00688-8cd1-35c5-e053-2995a90ab0111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-966-304586509663030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45865-966-30) 2019-12-110000-00-00NoNoCurrent