risedronate sodium

Product NDC

0591-2067

11-digit product format

005912067

Labeler code

0591

Product ID

0591-2067_41414f92-4457-410b-896b-9cf835a125b5

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

0000-00-00

Substance

RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE

Active strength

65 mg/1; mg/1

Pharmacologic classes

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

NDC exclude flag

No

Listing certified through

2021-12-31

Current FDA listing

Historical FDA.report record