Pioglitazone and Metformin Hydrochloride

Product NDC

42291-513

11-digit product format

422910513

Labeler code

42291

Product ID

42291-513_63a0189b-1147-838e-e053-2991aa0a8dc2

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Pioglitazone and Metformin Hydrochloride

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

AvKARE, Inc.

Application

ANDA091155

Marketing category

ANDA

Marketing start

2015-03-06

Marketing end

0000-00-00

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

2019-12-31

Current FDA listing

Historical FDA.report record