RIOMET ER

Product NDC

10631-019

11-digit product format

106310019

Labeler code

10631

Product ID

10631-019_e25cbd5f-37b8-4076-8fda-8dd0c3b19ad7

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Metformin Hydrochloride

Dosage form

FOR SUSPENSION, EXTENDED RELEASE

Route

ORAL

Labeler

Sun Pharmaceutical Industries Inc.

Application

NDA212595

Marketing category

NDA

Marketing start

2019-09-10

Marketing end

0000-00-00

Substance

METFORMIN HYDROCHLORIDE

Active strength

500 mg/5mL

Pharmacologic classes

Biguanide [EPC],Biguanides [CS]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record