Omeprazole

Product NDC
68016-759
11-digit product format
680160759
Labeler code
68016
Product ID
68016-759_9a635296-1a26-3b0d-e053-2995a90a0969
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Chain Drug Consortium, LLC
Application
ANDA078878
Marketing category
ANDA
Marketing start
2013-04-01
Marketing end
0000-00-00
Substance
OMEPRAZOLE MAGNESIUM
Active strength
21 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-759-14680160759141 BOTTLE in 1 CARTON (68016-759-14) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2016-09-010000-00-00NoNoCurrent
68016-759-28680160759282 BOTTLE in 1 CARTON (68016-759-28) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2016-09-010000-00-00NoNoCurrent
68016-759-42680160759423 BOTTLE in 1 CARTON (68016-759-42) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2016-09-010000-00-00NoNoCurrent