actoplus met

Generic: pioglitazone and metformin hydrochloride

Labeler: takeda pharmaceuticals america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name actoplus met
Generic Name pioglitazone and metformin hydrochloride
Labeler takeda pharmaceuticals america, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

metformin hydrochloride 850 mg/1, pioglitazone hydrochloride 15 mg/1

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 64764-158
Product ID 64764-158_271ff8ce-9ae5-4b65-8581-7ced42f47f2f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021842
Listing Expiration 2026-12-31
Marketing Start 2005-08-29

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 64764158
Hyphenated Format 64764-158

Supplemental Identifiers

RxCUI
861822 861824
UPC
0364764158606
UNII
786Z46389E 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 actoplus met (source: ndc)
Generic Name pioglitazone and metformin hydrochloride (source: ndc)
Application Number NDA021842 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 850 mg/1
  • 15 mg/1
source: ndc
Packaging
  • 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-158-18)
  • 4 CARTON in 1 TRAY (64764-158-41) / 1 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED in 1 BLISTER PACK
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-158-60)
source: ndc

Packages (3)

64764-158-18 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-158-18) 64764-158-41 4 CARTON in 1 TRAY (64764-158-41) / 1 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED in 1 BLISTER PACK 64764-158-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-158-60)

Ingredients (2)

metformin hydrochloride (850 mg/1) pioglitazone hydrochloride (15 mg/1)

Linked Drug Pages (1)

Actoplus Met ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "271ff8ce-9ae5-4b65-8581-7ced42f47f2f", "openfda": {"upc": ["0364764158606"], "unii": ["786Z46389E", "JQT35NPK6C"], "rxcui": ["861822", "861824"], "spl_set_id": ["42e49120-6f3f-11db-9fe1-0800200c9a66"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-158-18)", "package_ndc": "64764-158-18", "marketing_start_date": "20050829"}, {"sample": false, "description": "4 CARTON in 1 TRAY (64764-158-41)  / 1 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "64764-158-41", "marketing_start_date": "20050829"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-158-60)", "package_ndc": "64764-158-60", "marketing_start_date": "20050829"}], "brand_name": "Actoplus Met", "product_id": "64764-158_271ff8ce-9ae5-4b65-8581-7ced42f47f2f", "dosage_form": "TABLET, FILM COATED", "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": "64764-158", "generic_name": "pioglitazone and metformin hydrochloride", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Actoplus Met", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "850 mg/1"}, {"name": "PIOGLITAZONE HYDROCHLORIDE", "strength": "15 mg/1"}], "application_number": "NDA021842", "marketing_category": "NDA", "marketing_start_date": "20050829", "listing_expiration_date": "20261231"}