ASACOL HD

Product NDC

0430-0783

11-digit product format

004300783

Labeler code

0430

Product ID

0430-0783_3712f360-d3ac-407d-85bf-48e0d7f298cf

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

mesalamine

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

Labeler

Allergan, Inc.

Application

NDA021830

Marketing category

NDA

Marketing start

2008-05-28

Marketing end

2019-03-31

Substance

MESALAMINE

Active strength

800 mg/1

Pharmacologic classes

Aminosalicylate

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record