pioglitazone and metformin hydrochloride

Generic: pioglitazone and metformin hydrochloride

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

Drug Facts

Product Profile

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

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

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-176
Product ID 33342-176_c05a0d40-cee7-4a54-90e5-acd59e23f8f3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204802
Listing Expiration 2026-12-31
Marketing Start 2015-11-06

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 33342176
Hyphenated Format 33342-176

Supplemental Identifiers

RxCUI
861783 861822
UPC
0333342177117 0333342177094 0333342176448
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 and metformin hydrochloride (source: ndc)
Generic Name pioglitazone and metformin hydrochloride (source: ndc)
Application Number ANDA204802 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 15 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (33342-176-09)
  • 100 TABLET in 1 BOTTLE (33342-176-11)
  • 10 BLISTER PACK in 1 CARTON (33342-176-12) / 10 TABLET in 1 BLISTER PACK
  • 1000 TABLET in 1 BOTTLE (33342-176-44)
  • 180 TABLET in 1 BOTTLE (33342-176-57)
source: ndc

Packages (5)

33342-176-09 60 TABLET in 1 BOTTLE (33342-176-09) 33342-176-11 100 TABLET in 1 BOTTLE (33342-176-11) 33342-176-12 10 BLISTER PACK in 1 CARTON (33342-176-12) / 10 TABLET in 1 BLISTER PACK 33342-176-44 1000 TABLET in 1 BOTTLE (33342-176-44) 33342-176-57 180 TABLET in 1 BOTTLE (33342-176-57)

Ingredients (2)

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

Linked Drug Pages (1)

Pioglitazone and metformin hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c05a0d40-cee7-4a54-90e5-acd59e23f8f3", "openfda": {"upc": ["0333342177117", "0333342177094", "0333342176448"], "unii": ["JQT35NPK6C", "786Z46389E"], "rxcui": ["861783", "861822"], "spl_set_id": ["5ff2cd9e-a579-48f5-845f-c37a68372a34"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (33342-176-09)", "package_ndc": "33342-176-09", "marketing_start_date": "20151106"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (33342-176-11)", "package_ndc": "33342-176-11", "marketing_start_date": "20151106"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-176-12)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "33342-176-12", "marketing_start_date": "20151106"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (33342-176-44)", "package_ndc": "33342-176-44", "marketing_start_date": "20151106"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (33342-176-57)", "package_ndc": "33342-176-57", "marketing_start_date": "20151106"}], "brand_name": "Pioglitazone and metformin hydrochloride", "product_id": "33342-176_c05a0d40-cee7-4a54-90e5-acd59e23f8f3", "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": "33342-176", "generic_name": "Pioglitazone and metformin hydrochloride", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pioglitazone and metformin hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}, {"name": "PIOGLITAZONE HYDROCHLORIDE", "strength": "15 mg/1"}], "application_number": "ANDA204802", "marketing_category": "ANDA", "marketing_start_date": "20151106", "listing_expiration_date": "20261231"}