pioglitazone hydrochloride

Generic: pioglitazone hydrochloride

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pioglitazone hydrochloride
Generic Name pioglitazone hydrochloride
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pioglitazone hydrochloride 45 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4519
Product ID 70518-4519_4390d6f4-41fe-9b18-e063-6394a90a8031
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200268
Listing Expiration 2026-12-31
Marketing Start 2025-11-14

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 705184519
Hyphenated Format 70518-4519

Supplemental Identifiers

RxCUI
312441
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 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
  • 90 TABLET in 1 BOTTLE, PLASTIC (70518-4519-0)
source: ndc

Packages (1)

70518-4519-0 90 TABLET in 1 BOTTLE, PLASTIC (70518-4519-0)

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": "4390d6f4-41fe-9b18-e063-6394a90a8031", "openfda": {"unii": ["JQT35NPK6C"], "rxcui": ["312441"], "spl_set_id": ["04577c39-a9c0-4c66-a775-4c79e2c3dea5"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (70518-4519-0)", "package_ndc": "70518-4519-0", "marketing_start_date": "20251114"}], "brand_name": "PIOGLITAZONE HYDROCHLORIDE", "product_id": "70518-4519_4390d6f4-41fe-9b18-e063-6394a90a8031", "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": "70518-4519", "generic_name": "pioglitazone hydrochloride", "labeler_name": "REMEDYREPACK INC.", "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": "20251114", "listing_expiration_date": "20261231"}