MESALAMINE

Product NDC
59762-0117
11-digit product format
597620117
Labeler code
59762
Product ID
59762-0117_c3d5de78-0345-4b06-9adc-61923c4ea43d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MESALAMINE
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Greenstone LLC
Application
NDA204412
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-05-10
Marketing end
0000-00-00
Substance
MESALAMINE
Active strength
400 mg/1
Pharmacologic classes
Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-0117-1EA - Each59762-01174b6efca6-cbff-486a-a0c2-dd7cf993825d12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-0117MESALAMINE CAPSULE, DELAYED RELEASE [GREENSTONE LLC]12Legacy NDC20250221_370bd908-55af-4dfc-8837-913bf73babbd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59762-0117-159762011701180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59762-0117-1) 2019-05-100000-00-00NoNoCurrent