pioglitazone

Generic: pioglitazone

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pioglitazone
Generic Name pioglitazone
Labeler macleods pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pioglitazone hydrochloride 15 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-054
Product ID 33342-054_7d118937-d5b2-402f-8e24-f70a48c1d432
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202467
Listing Expiration 2026-12-31
Marketing Start 2013-02-14

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 33342054
Hyphenated Format 33342-054

Supplemental Identifiers

RxCUI
312440 312441 317573
UPC
0333342056153 0333342055101 0333342056078 0333342056108 0333342054104 0333342055071
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 (source: ndc)
Generic Name pioglitazone (source: ndc)
Application Number ANDA202467 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (33342-054-07)
  • 90 TABLET in 1 BOTTLE (33342-054-10)
  • 100 TABLET in 1 BOX, UNIT-DOSE (33342-054-12)
  • 500 TABLET in 1 BOTTLE (33342-054-15)
source: ndc

Packages (4)

33342-054-07 30 TABLET in 1 BOTTLE (33342-054-07) 33342-054-10 90 TABLET in 1 BOTTLE (33342-054-10) 33342-054-12 100 TABLET in 1 BOX, UNIT-DOSE (33342-054-12) 33342-054-15 500 TABLET in 1 BOTTLE (33342-054-15)

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": "7d118937-d5b2-402f-8e24-f70a48c1d432", "openfda": {"upc": ["0333342056153", "0333342055101", "0333342056078", "0333342056108", "0333342054104", "0333342055071"], "unii": ["JQT35NPK6C"], "rxcui": ["312440", "312441", "317573"], "spl_set_id": ["482cef76-0623-4b4f-a0ea-f008c97b2281"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (33342-054-07)", "package_ndc": "33342-054-07", "marketing_start_date": "20130214"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (33342-054-10)", "package_ndc": "33342-054-10", "marketing_start_date": "20130214"}, {"sample": false, "description": "100 TABLET in 1 BOX, UNIT-DOSE (33342-054-12)", "package_ndc": "33342-054-12", "marketing_start_date": "20130214"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (33342-054-15)", "package_ndc": "33342-054-15", "marketing_start_date": "20130214"}], "brand_name": "Pioglitazone", "product_id": "33342-054_7d118937-d5b2-402f-8e24-f70a48c1d432", "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": "33342-054", "generic_name": "Pioglitazone", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pioglitazone", "active_ingredients": [{"name": "PIOGLITAZONE HYDROCHLORIDE", "strength": "15 mg/1"}], "application_number": "ANDA202467", "marketing_category": "ANDA", "marketing_start_date": "20130214", "listing_expiration_date": "20261231"}