Pioglitazone Hydrochloride and Metformin Hydrochloride

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Aurobindo Pharma Limited

DUNS Number

650082092

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Aurobindo Pharma Limited

Labeler

Rising Pharma Holdings, Inc.

Registrant

Aurobindo Pharma Limited

DUNS Number

650381903

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

57237-217

Application Number

ANDA200823

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 27, 2022

Ingredients

PioglitazoneActive

Code: JQT35NPK6CClass: ACTIMQuantity: 15 mg in 1 1

CARBOXYMETHYLCELLULOSE CALCIUMInactive

Code: UTY7PDF93LClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

MetforminActive

Code: 786Z46389EClass: ACTIBQuantity: 500 mg in 1 1

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT