Omeprazole

Product NDC
0904-6144
11-digit product format
009046144
Labeler code
0904
Product ID
0904-6144_bd975546-1306-4e76-8493-d0735369589b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA076515
Marketing category
ANDA
Marketing start
2010-07-16
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6144-61EA - Each0904-61446cc0949f-d564-469b-bb45-c1e22e9294d912012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6144-6100904614461100 BLISTER PACK in 1 CARTON (0904-6144-61) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK100 blister pack2010-07-160000-00-00NoNoCurrent