Risedronate Sodium

Product NDC

0591-3876

11-digit product format

005913876

Labeler code

0591

Product ID

0591-3876_cbad3736-ad79-475b-b35d-b9fce4923650

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

risedronate sodium

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

Labeler

Actavis Pharma, Inc.

Application

NDA022560

Marketing category

NDA

Marketing start

2010-12-01

Marketing end

0000-00-00

Substance

RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE

Active strength

30 mg/1; mg/1

Pharmacologic classes

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

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record