Omeprazole

Product NDC
16714-747
11-digit product format
167140747
Labeler code
16714
Product ID
16714-747_035e50ac-e188-4fe3-a3d0-dcfc172cfba7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA203270
Marketing category
ANDA
Marketing start
2015-08-19
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
20 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-747-01EA - Each16714-74762a73998-8e38-465f-9c04-e6be0692de8612018-03-08
16714-747-02EA - Each16714-74768519cdb-2601-4419-b911-278edf4cf98e12018-03-08
16714-747-03EA - Each16714-7471be495a2-f1bb-4655-ae94-0f66215b1c0112018-03-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN9e1d4d1e-9432-4236-a4b8-20d3fb0a0ee13
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD9e1d4d1e-9432-4236-a4b8-20d3fb0a0ee13
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY9e1d4d1e-9432-4236-a4b8-20d3fb0a0ee13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-747-011671407470130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-747-01) 2015-08-190000-00-00NoNoCurrent
16714-747-0216714074702100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-747-02) 2015-08-190000-00-00NoNoCurrent
16714-747-03167140747031000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-747-03) 2015-08-190000-00-00NoNoCurrent