pioglitazone hydrochloride

Generic: pioglitazone hydrochloride

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pioglitazone hydrochloride
Generic Name pioglitazone hydrochloride
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pioglitazone hydrochloride 30 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-513
Product ID 65862-513_75b48749-1268-4752-8a50-83382f05c951
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200268
Listing Expiration 2026-12-31
Marketing Start 2013-02-13

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 65862513
Hyphenated Format 65862-513

Supplemental Identifiers

RxCUI
312440 312441 317573
UPC
0365862513106 0365862513304 0365862512109 0365862514103 0365862512307 0365862514301
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
  • 30 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (65862-513-05)
  • 3 BLISTER PACK in 1 CARTON (65862-513-10) / 10 TABLET in 1 BLISTER PACK
  • 30 TABLET in 1 BOTTLE (65862-513-30)
  • 90 TABLET in 1 BOTTLE (65862-513-90)
source: ndc

Packages (4)

65862-513-05 500 TABLET in 1 BOTTLE (65862-513-05) 65862-513-10 3 BLISTER PACK in 1 CARTON (65862-513-10) / 10 TABLET in 1 BLISTER PACK 65862-513-30 30 TABLET in 1 BOTTLE (65862-513-30) 65862-513-90 90 TABLET in 1 BOTTLE (65862-513-90)

Ingredients (1)

pioglitazone hydrochloride (30 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": "75b48749-1268-4752-8a50-83382f05c951", "openfda": {"upc": ["0365862513106", "0365862513304", "0365862512109", "0365862514103", "0365862512307", "0365862514301"], "unii": ["JQT35NPK6C"], "rxcui": ["312440", "312441", "317573"], "spl_set_id": ["1f259863-21fd-4d62-b094-4eff845944df"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (65862-513-05)", "package_ndc": "65862-513-05", "marketing_start_date": "20130213"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (65862-513-10)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "65862-513-10", "marketing_start_date": "20130213"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (65862-513-30)", "package_ndc": "65862-513-30", "marketing_start_date": "20130213"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (65862-513-90)", "package_ndc": "65862-513-90", "marketing_start_date": "20190614"}], "brand_name": "PIOGLITAZONE HYDROCHLORIDE", "product_id": "65862-513_75b48749-1268-4752-8a50-83382f05c951", "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": "65862-513", "generic_name": "pioglitazone hydrochloride", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PIOGLITAZONE HYDROCHLORIDE", "active_ingredients": [{"name": "PIOGLITAZONE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA200268", "marketing_category": "ANDA", "marketing_start_date": "20130213", "listing_expiration_date": "20261231"}