Risedronate Sodium

Product NDC

0378-4150

11-digit product format

003784150

Labeler code

0378

Product ID

0378-4150_a55eb183-58db-4f47-8b9b-51e20449860c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

risedronate sodium

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Mylan Pharmaceuticals Inc.

Application

ANDA200477

Marketing category

ANDA

Marketing start

2014-06-10

Marketing end

0000-00-00

Substance

RISEDRONATE SODIUM

Active strength

150 mg/1

Pharmacologic classes

Bisphosphonate [EPC],Diphosphonates [CS]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record