Pioglitazone Hydrochloride and Metformin Hydrochloride

Product NDC

0378-1575

11-digit product format

003781575

Labeler code

0378

Product ID

0378-1575_4229b266-ce42-45af-b41b-0426f025179b

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

pioglitazone hydrochloride and metformin hydrochloride

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Mylan Pharmaceuticals Inc.

Application

ANDA090406

Marketing category

ANDA

Marketing start

2012-08-17

Marketing end

2019-06-30

Substance

PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE

Active strength

15 mg/1; mg/1

Pharmacologic classes

Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Biguanide [EPC],Biguanides [CS]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record