pioglitazone hydrochloride

Generic: pioglitazone hydrochloride

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pioglitazone hydrochloride
Generic Name pioglitazone hydrochloride
Labeler quallent pharmaceuticals health llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pioglitazone hydrochloride 45 mg/1

Manufacturer
QUALLENT PHARMACEUTICALS HEALTH LLC

Identifiers & Regulatory

Product NDC 82009-105
Product ID 82009-105_c628bc60-920f-4d54-b41e-820aaccff112
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200268
Listing Expiration 2026-12-31
Marketing Start 2023-08-01

Pharmacologic Class

Classes
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 82009105
Hyphenated Format 82009-105

Supplemental Identifiers

RxCUI
312440 312441 317573
UNII
JQT35NPK6C

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 (source: ndc)
Generic Name pioglitazone hydrochloride (source: ndc)
Application Number ANDA200268 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 45 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (82009-105-05)
source: ndc

Packages (1)

82009-105-05 500 TABLET in 1 BOTTLE (82009-105-05)

Ingredients (1)

pioglitazone hydrochloride (45 mg/1)

Linked Drug Pages (1)

PIOGLITAZONE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c628bc60-920f-4d54-b41e-820aaccff112", "openfda": {"unii": ["JQT35NPK6C"], "rxcui": ["312440", "312441", "317573"], "spl_set_id": ["0331400c-b163-4856-bfb0-965470247cb3"], "manufacturer_name": ["QUALLENT PHARMACEUTICALS HEALTH LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (82009-105-05)", "package_ndc": "82009-105-05", "marketing_start_date": "20230801"}], "brand_name": "PIOGLITAZONE HYDROCHLORIDE", "product_id": "82009-105_c628bc60-920f-4d54-b41e-820aaccff112", "dosage_form": "TABLET", "pharm_class": ["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": "82009-105", "generic_name": "pioglitazone hydrochloride", "labeler_name": "QUALLENT PHARMACEUTICALS HEALTH LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PIOGLITAZONE HYDROCHLORIDE", "active_ingredients": [{"name": "PIOGLITAZONE HYDROCHLORIDE", "strength": "45 mg/1"}], "application_number": "ANDA200268", "marketing_category": "ANDA", "marketing_start_date": "20230801", "listing_expiration_date": "20261231"}