mesalamine

Product NDC
63629-8827
11-digit product format
636298827
Labeler code
63629
Product ID
63629-8827_64ba024f-13af-47b9-9b25-ef2b6cb28dcf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mesalamine
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA022301
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2021-01-05
Marketing end
0000-00-00
Substance
MESALAMINE
Active strength
375 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
63629-8827-1EA - Each63629-8827a84bf8e3-86a5-4e69-9e75-1f7f88292e3f12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8827MESALAMINE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]103Legacy NDC20240724_e6cba87c-8346-4221-a01f-adeded8cee11.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8827-163629882701120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-8827-1) 2021-09-100000-00-00NoNoCurrent