Isosorbide

Product NDC

0143-2260

11-digit product format

001432260

Labeler code

0143

Product ID

0143-2260_3a032922-f0d8-45d9-9c76-5a1bcc4b9b6f

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Isosorbide mononitrate

Dosage form

TABLET, FILM COATED, EXTENDED RELEASE

Route

ORAL

Labeler

Hikma Pharmaceuticals USA Inc.

Application

ANDA076813

Marketing category

ANDA

Marketing start

2006-03-30

Marketing end

2020-12-31

Substance

ISOSORBIDE MONONITRATE

Active strength

60 mg/1

Pharmacologic classes

Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record