pioglitazone hcl and metformin hcl

Generic: pioglitazone hcl and metformin hcl

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

Drug Facts

Product Profile

Brand Name pioglitazone hcl and metformin hcl
Generic Name pioglitazone hcl and metformin hcl
Labeler torrent pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1, pioglitazone hydrochloride 15 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-280
Product ID 13668-280_d3ee8181-154a-4042-91e9-18b51ddc8994
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202001
Listing Expiration 2026-12-31
Marketing Start 2025-09-01

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs] 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 13668280
Hyphenated Format 13668-280

Supplemental Identifiers

RxCUI
861783 861822
UPC
0313668280609 0313668281606
UNII
JQT35NPK6C 786Z46389E

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 hcl and metformin hcl (source: ndc)
Generic Name pioglitazone hcl and metformin hcl (source: ndc)
Application Number ANDA202001 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 15 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (13668-280-05)
  • 1000 TABLET in 1 BOTTLE (13668-280-10)
  • 180 TABLET in 1 BOTTLE (13668-280-33)
  • 60 TABLET in 1 BOTTLE (13668-280-60)
  • 100 TABLET in 1 CARTON (13668-280-74)
source: ndc

Packages (5)

13668-280-05 500 TABLET in 1 BOTTLE (13668-280-05) 13668-280-10 1000 TABLET in 1 BOTTLE (13668-280-10) 13668-280-33 180 TABLET in 1 BOTTLE (13668-280-33) 13668-280-60 60 TABLET in 1 BOTTLE (13668-280-60) 13668-280-74 100 TABLET in 1 CARTON (13668-280-74)

Ingredients (2)

metformin hydrochloride (500 mg/1) pioglitazone hydrochloride (15 mg/1)

Linked Drug Pages (1)

Pioglitazone HCL and Metformin HCL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d3ee8181-154a-4042-91e9-18b51ddc8994", "openfda": {"upc": ["0313668280609", "0313668281606"], "unii": ["JQT35NPK6C", "786Z46389E"], "rxcui": ["861783", "861822"], "spl_set_id": ["237d8fa2-633c-4c29-84d3-f1b413610dc3"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (13668-280-05)", "package_ndc": "13668-280-05", "marketing_start_date": "20250901"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (13668-280-10)", "package_ndc": "13668-280-10", "marketing_start_date": "20250901"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (13668-280-33)", "package_ndc": "13668-280-33", "marketing_start_date": "20250901"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (13668-280-60)", "package_ndc": "13668-280-60", "marketing_start_date": "20250901"}, {"sample": false, "description": "100 TABLET in 1 CARTON (13668-280-74)", "package_ndc": "13668-280-74", "marketing_start_date": "20250901"}], "brand_name": "Pioglitazone HCL and Metformin HCL", "product_id": "13668-280_d3ee8181-154a-4042-91e9-18b51ddc8994", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "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": "13668-280", "generic_name": "Pioglitazone HCL and Metformin HCL", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pioglitazone HCL and Metformin HCL", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}, {"name": "PIOGLITAZONE HYDROCHLORIDE", "strength": "15 mg/1"}], "application_number": "ANDA202001", "marketing_category": "ANDA", "marketing_start_date": "20250901", "listing_expiration_date": "20261231"}