risedronate sodium

Product NDC

0591-2109

11-digit product format

005912109

Labeler code

0591

Product ID

0591-2109_77563bfa-9732-4d38-b5ca-f11f1a5fb2ed

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

risedronate sodium

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Actavis Pharma, Inc.

Application

NDA020835

Marketing category

NDA AUTHORIZED GENERIC

Marketing start

2014-06-27

Marketing end

2020-02-28

Substance

RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE

Active strength

26 mg/1; mg/1

Pharmacologic classes

Bisphosphonate [EPC],Diphosphonates [CS],Bisphosphonate [EPC],Diphosphonates [CS]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record