Omeprazole

Product NDC
50090-5903
11-digit product format
500905903
Labeler code
50090
Product ID
50090-5903_95b7e297-fda2-4e1e-ac9a-6fb571173687
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA212977
Marketing category
ANDA
Marketing start
2019-02-20
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5903-0EA - Each50090-5903999cdc4c-1f87-4d64-b9fc-72e464273cc212022-06-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5903-05009059030032 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5903-0) 2022-01-130000-00-00NoNoCurrent