Omeprazole Magnesium

Product NDC
55319-916
11-digit product format
553190916
Labeler code
55319
Product ID
55319-916_1acd0db6-b99f-a6ee-e74f-77022a0521e8
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Family Dollar Stores, Inc.
Application
ANDA078878
Marketing category
ANDA
Marketing start
2012-08-10
Marketing end
0000-00-00
Substance
OMEPRAZOLE MAGNESIUM
Active strength
20 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-916OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [FAMILY DOLLAR STORES, INC. ]4Legacy NDC20190202_5f7fa2cf-5a2f-3bb6-6dc9-2b0cb080b80a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55319-916-27553190916272 BOTTLE in 1 CARTON (55319-916-27) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2017-06-090000-00-00NoNoCurrent
55319-916-33553190916333 BOTTLE in 1 CARTON (55319-916-33) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2012-08-100000-00-00NoNoCurrent
55319-916-52553190916521 BOTTLE in 1 CARTON (55319-916-52) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2012-10-110000-00-00NoNoCurrent