pioglitazone hydrochloride and metformin hydrochloride (57237-217)

Drug Facts

Product Profile

Brand Name pioglitazone hydrochloride and metformin hydrochloride

Generic Name pioglitazone hydrochloride and metformin hydrochloride

Labeler rising pharma holdings, inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

metformin hydrochloride 500 mg/1, pioglitazone hydrochloride 15 mg/1

Manufacturer

Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 57237-217

Product ID 57237-217_e1c4f0ca-4474-4bac-8884-8180e7aec050

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 57237217

Hyphenated Format 57237-217

Supplemental Identifiers

RxCUI

861783 861822

UPC

0357237218600 0357237217603

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

500 mg/1
15 mg/1

source: ndc

Packaging

60 TABLET, FILM COATED in 1 BOTTLE (57237-217-60)
180 TABLET, FILM COATED in 1 BOTTLE (57237-217-81)

source: ndc

Packages (2)

57237-217-60 60 TABLET, FILM COATED in 1 BOTTLE (57237-217-60) 57237-217-81 180 TABLET, FILM COATED in 1 BOTTLE (57237-217-81)

Ingredients (2)

metformin hydrochloride (500 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

{"route": ["ORAL"], "spl_id": "e1c4f0ca-4474-4bac-8884-8180e7aec050", "openfda": {"upc": ["0357237218600", "0357237217603"], "unii": ["JQT35NPK6C", "786Z46389E"], "rxcui": ["861783", "861822"], "spl_set_id": ["8d252dab-e868-42d3-95ea-69423d909e84"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (57237-217-60)", "package_ndc": "57237-217-60", "marketing_start_date": "20130213"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (57237-217-81)", "package_ndc": "57237-217-81", "marketing_start_date": "20130213"}], "brand_name": "Pioglitazone Hydrochloride and Metformin Hydrochloride", "product_id": "57237-217_e1c4f0ca-4474-4bac-8884-8180e7aec050", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["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]"], "product_ndc": "57237-217", "generic_name": "Pioglitazone Hydrochloride and Metformin Hydrochloride", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pioglitazone Hydrochloride and Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}, {"name": "PIOGLITAZONE HYDROCHLORIDE", "strength": "15 mg/1"}], "application_number": "ANDA200823", "marketing_category": "ANDA", "marketing_start_date": "20130213", "listing_expiration_date": "20261231"}