pioglitazone

Generic: pioglitazone

Labeler: solco healthcare llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pioglitazone
Generic Name pioglitazone
Labeler solco healthcare llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pioglitazone 45 mg/1

Manufacturer
Solco Healthcare LLC

Identifiers & Regulatory

Product NDC 43547-428
Product ID 43547-428_258c9ca5-41a1-44dc-8d3a-958bf6613e40
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207806
Listing Expiration 2026-12-31
Marketing Start 2018-05-20

Pharmacologic Class

Established (EPC)
peroxisome proliferator receptor alpha agonist [epc] peroxisome proliferator receptor gamma agonist [epc] thiazolidinedione [epc]
Mechanism of Action
peroxisome proliferator-activated receptor alpha agonists [moa] peroxisome proliferator-activated receptor gamma agonists [moa]
Chemical Structure
thiazolidinediones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43547428
Hyphenated Format 43547-428

Supplemental Identifiers

RxCUI
312440 312441 317573
UPC
0343547428099 0343547426095
UNII
X4OV71U42S
NUI
N0000175596 N0000175375 N0000180186 N0000175377 N0000180190 M0447306

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 (source: ndc)
Generic Name pioglitazone (source: ndc)
Application Number ANDA207806 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 45 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (43547-428-03)
  • 90 TABLET in 1 BOTTLE (43547-428-09)
  • 500 TABLET in 1 BOTTLE (43547-428-50)
source: ndc

Packages (3)

43547-428-03 30 TABLET in 1 BOTTLE (43547-428-03) 43547-428-09 90 TABLET in 1 BOTTLE (43547-428-09) 43547-428-50 500 TABLET in 1 BOTTLE (43547-428-50)

Ingredients (1)

pioglitazone (45 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": "258c9ca5-41a1-44dc-8d3a-958bf6613e40", "openfda": {"nui": ["N0000175596", "N0000175375", "N0000180186", "N0000175377", "N0000180190", "M0447306"], "upc": ["0343547428099", "0343547426095"], "unii": ["X4OV71U42S"], "rxcui": ["312440", "312441", "317573"], "spl_set_id": ["1b77dbeb-61d1-4df3-872b-2f4f75a110db"], "pharm_class_cs": ["Thiazolidinediones [CS]"], "pharm_class_epc": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]", "Peroxisome Proliferator Receptor gamma Agonist [EPC]", "Thiazolidinedione [EPC]"], "pharm_class_moa": ["Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]", "Peroxisome Proliferator-activated Receptor gamma Agonists [MoA]"], "manufacturer_name": ["Solco Healthcare LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (43547-428-03)", "package_ndc": "43547-428-03", "marketing_start_date": "20180520"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (43547-428-09)", "package_ndc": "43547-428-09", "marketing_start_date": "20180520"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (43547-428-50)", "package_ndc": "43547-428-50", "marketing_start_date": "20180520"}], "brand_name": "PIOGLITAZONE", "product_id": "43547-428_258c9ca5-41a1-44dc-8d3a-958bf6613e40", "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": "43547-428", "generic_name": "Pioglitazone", "labeler_name": "Solco Healthcare LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PIOGLITAZONE", "active_ingredients": [{"name": "PIOGLITAZONE", "strength": "45 mg/1"}], "application_number": "ANDA207806", "marketing_category": "ANDA", "marketing_start_date": "20180520", "listing_expiration_date": "20261231"}