Mesalamine

Product NDC
72162-2231
11-digit product format
721622231
Labeler code
72162
Product ID
72162-2231_baa76dde-3c5b-4ff4-ba0c-f19660a796c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mesalamine
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203817
Marketing category
ANDA
Marketing start
2018-03-26
Substance
MESALAMINE
Active strength
1.2 g/1
Pharmacologic classes
Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
4Q81I59GXCMESALAMINE89-57-6MESALAMINE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2231-272162223102120 TABLET, DELAYED RELEASE in 1 BOTTLE (72162-2231-2) 2024-08-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
MesalamineBryant Ranch Prepack2024-08-14HUMAN PRESCRIPTION DRUG LABEL102