OMEPRAZOLE

Product NDC
71610-297
11-digit product format
716100297
Labeler code
71610
Product ID
71610-297_3f1e716a-a86d-4096-9f15-42f9234b61c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OMEPRAZOLE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA203481
Marketing category
ANDA
Marketing start
2017-07-03
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
71610-297-60OMEPRAZOLE90 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-297OMEPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 1 package rows20190629_d1044e87-8bd9-4c21-a1c3-12c456c52e05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSNd1044e87-8bd9-4c21-a1c3-12c456c52e051
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDd1044e87-8bd9-4c21-a1c3-12c456c52e051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-297-607161002976090 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-297-60) 2019-06-280000-00-00NoNoCurrent