pioglitazone

Generic: pioglitazone

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pioglitazone
Generic Name pioglitazone
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pioglitazone hydrochloride 15 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-495
Product ID 71610-495_35580504-c655-4630-8432-b54e6c71218d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200268
Listing Expiration 2026-12-31
Marketing Start 2013-02-13

Pharmacologic Class

Classes
ppar alpha [cs] ppar gamma [cs] peroxisome proliferator receptor alpha agonist [epc] peroxisome proliferator receptor gamma agonist [epc] peroxisome proliferator-activated receptor activity [moa] thiazolidinedione [epc] thiazolidinediones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610495
Hyphenated Format 71610-495

Supplemental Identifiers

RxCUI
317573
UNII
JQT35NPK6C

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

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (71610-495-60)
source: ndc

Packages (1)

71610-495-60 90 TABLET in 1 BOTTLE (71610-495-60)

Ingredients (1)

pioglitazone hydrochloride (15 mg/1)

Linked Drug Pages (1)

Pioglitazone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "35580504-c655-4630-8432-b54e6c71218d", "openfda": {"unii": ["JQT35NPK6C"], "rxcui": ["317573"], "spl_set_id": ["f434ba0d-13f3-42ae-a2d5-cddb93fde1e8"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-495-60)", "package_ndc": "71610-495-60", "marketing_start_date": "20201117"}], "brand_name": "Pioglitazone", "product_id": "71610-495_35580504-c655-4630-8432-b54e6c71218d", "dosage_form": "TABLET", "pharm_class": ["PPAR alpha [CS]", "PPAR gamma [CS]", "Peroxisome Proliferator Receptor alpha Agonist [EPC]", "Peroxisome Proliferator Receptor gamma Agonist [EPC]", "Peroxisome Proliferator-activated Receptor Activity [MoA]", "Thiazolidinedione [EPC]", "Thiazolidinediones [CS]"], "product_ndc": "71610-495", "generic_name": "Pioglitazone", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pioglitazone", "active_ingredients": [{"name": "PIOGLITAZONE HYDROCHLORIDE", "strength": "15 mg/1"}], "application_number": "ANDA200268", "marketing_category": "ANDA", "marketing_start_date": "20130213", "listing_expiration_date": "20261231"}