Omeprazole

Product NDC
16714-746
11-digit product format
167140746
Labeler code
16714
Product ID
16714-746_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
10 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-746-01EA - Each16714-746868d6221-eba2-4102-94d9-e5196db0fc4e12018-03-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-746-011671407460130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-746-01) 2015-08-190000-00-00NoNoCurrent