Omeprazole

Product NDC
42708-080
11-digit product format
427080080
Labeler code
42708
Product ID
42708-080_bcbab676-fbdc-f0cc-e053-2a95a90ad4d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
QPharma Inc
Application
ANDA076048
Marketing category
ANDA
Marketing start
2003-11-11
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42708-080-144270800801414 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42708-080-14) 2018-06-220000-00-00YesNoCurrent