pioglitazone hydrochloride and metformin hydrochloride (65862-526)

Drug Facts

Product Profile

Brand Name pioglitazone hydrochloride and metformin hydrochloride

Generic Name pioglitazone hydrochloride and metformin hydrochloride

Labeler aurobindo pharma limited

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

metformin hydrochloride 850 mg/1, pioglitazone hydrochloride 15 mg/1

Manufacturer

Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-526

Product ID 65862-526_1468f2ff-4355-402a-8c46-0b9272ae633e

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA200823

Listing Expiration 2026-12-31

Marketing Start 2013-02-13

Pharmacologic Class

Classes

biguanide [epc] biguanides [cs] peroxisome proliferator receptor alpha agonist [epc] peroxisome proliferator receptor gamma agonist [epc] peroxisome proliferator-activated receptor alpha agonists [moa] peroxisome proliferator-activated receptor gamma agonists [moa] thiazolidinedione [epc] thiazolidinediones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862526

Hyphenated Format 65862-526

Supplemental Identifiers

RxCUI

861783 861822

UNII

JQT35NPK6C 786Z46389E

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pioglitazone hydrochloride and metformin hydrochloride (source: ndc)

Generic Name pioglitazone hydrochloride and metformin hydrochloride (source: ndc)

Application Number ANDA200823 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

850 mg/1
15 mg/1

source: ndc

Packaging

180 TABLET, FILM COATED in 1 BOTTLE (65862-526-18)
60 TABLET, FILM COATED in 1 BOTTLE (65862-526-60)

source: ndc

Packages (2)

65862-526-18 180 TABLET, FILM COATED in 1 BOTTLE (65862-526-18) 65862-526-60 60 TABLET, FILM COATED in 1 BOTTLE (65862-526-60)

Ingredients (2)

metformin hydrochloride (850 mg/1) pioglitazone hydrochloride (15 mg/1)

Linked Drug Pages (1)

Pioglitazone Hydrochloride and Metformin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

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