Omeprazole

Product NDC
48433-327
11-digit product format
484330327
Labeler code
48433
Product ID
48433-327_6b537019-dd14-44af-a03f-a0853afa72b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Safecor Health, LLC
Application
ANDA076048
Marketing category
ANDA
Marketing start
2014-09-30
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
20 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record