mesalamine

Product NDC

68382-484

11-digit product format

683820484

Labeler code

68382

Product ID

68382-484_0325121b-d673-4251-8d7d-f9e79869afe8

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

mesalamine

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

Labeler

Zydus Pharmaceuticals (USA) Inc.

Application

NDA021830

Marketing category

NDA AUTHORIZED GENERIC

Marketing start

2016-08-01

Marketing end

0000-00-00

Substance

MESALAMINE

Active strength

800 mg/1

Pharmacologic classes

Aminosalicylate [EPC],Aminosalicylic Acids [CS]

NDC exclude flag

E

Listing certified through

2018-12-31

Current FDA listing

Historical FDA.report record