Omeprazole

Product NDC
67046-700
11-digit product format
670460700
Labeler code
67046
Product ID
67046-700_74f89ebc-df4b-cace-e053-2991aa0a65e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA075757
Marketing category
ANDA
Marketing start
2003-01-28
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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
67046-700-30Omeprazole30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE301
67046-700-60Omeprazole60 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-700OMEPRAZOLE CAPSULE, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 2 package rows20181230_74f888ce-5f95-cad0-e053-2991aa0a2d79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN74f888ce-5f95-cad0-e053-2991aa0a2d791
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD74f888ce-5f95-cad0-e053-2991aa0a2d791
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY74f888ce-5f95-cad0-e053-2991aa0a2d791

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67046-700-306704607003030 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (67046-700-30) 2018-05-310000-00-00NoNoCurrent
67046-700-606704607006060 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (67046-700-60) 2018-05-310000-00-00NoNoCurrent