Esomeprazole

Product NDC
63304-740
11-digit product format
633040740
Labeler code
63304
Product ID
63304-740_6ac3f3a4-98df-4eb3-9b9e-c85253811b85
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA212866
Marketing category
ANDA
Marketing start
2019-11-30
Marketing end
0000-00-00
Substance
ESOMEPRAZOLE MAGNESIUM
Active strength
20 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-740ESOMEPRAZOLE CAPSULE, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]5Legacy NDC20200513_86aa9813-351c-4fbe-80f6-4f861f25fe1d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63304-740-14633040740141 BOTTLE in 1 CARTON (63304-740-14) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2019-11-300000-00-00NoNoCurrent
63304-740-27633040740272 BOTTLE in 1 CARTON (63304-740-27) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2019-11-300000-00-00NoNoCurrent
63304-740-44633040740443 BOTTLE in 1 CARTON (63304-740-44) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2019-11-300000-00-00NoNoCurrent