pioglitazone hydrochloride

Generic: pioglitazone hydrochloride

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pioglitazone hydrochloride
Generic Name pioglitazone hydrochloride
Labeler chartwell rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pioglitazone hydrochloride 30 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-805
Product ID 62135-805_42c9ddc6-1aae-a645-e063-6294a90a8b1a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076798
Listing Expiration 2026-12-31
Marketing Start 2020-10-28

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 62135805
Hyphenated Format 62135-805

Supplemental Identifiers

RxCUI
312440 312441 317573
UPC
0362135804305 0362135806309 0362135805302
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 ANDA076798 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (62135-805-30)
  • 90 TABLET in 1 BOTTLE (62135-805-90)
source: ndc

Packages (2)

62135-805-30 30 TABLET in 1 BOTTLE (62135-805-30) 62135-805-90 90 TABLET in 1 BOTTLE (62135-805-90)

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": "42c9ddc6-1aae-a645-e063-6294a90a8b1a", "openfda": {"upc": ["0362135804305", "0362135806309", "0362135805302"], "unii": ["JQT35NPK6C"], "rxcui": ["312440", "312441", "317573"], "spl_set_id": ["699e865a-952e-459e-a871-9b7cce475b71"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (62135-805-30)", "package_ndc": "62135-805-30", "marketing_start_date": "20240822"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (62135-805-90)", "package_ndc": "62135-805-90", "marketing_start_date": "20240822"}], "brand_name": "PIOGLITAZONE HYDROCHLORIDE", "product_id": "62135-805_42c9ddc6-1aae-a645-e063-6294a90a8b1a", "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": "62135-805", "generic_name": "PIOGLITAZONE HYDROCHLORIDE", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PIOGLITAZONE HYDROCHLORIDE", "active_ingredients": [{"name": "PIOGLITAZONE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA076798", "marketing_category": "ANDA", "marketing_start_date": "20201028", "listing_expiration_date": "20261231"}