actos

Generic: pioglitazone

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

Drug Facts

Product Profile

Brand Name actos
Generic Name pioglitazone
Labeler takeda pharmaceuticals america, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pioglitazone hydrochloride 45 mg/1

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 64764-451
Product ID 64764-451_20e43dff-4bf2-4ae7-82a1-e7e895123f93
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021073
Listing Expiration 2026-12-31
Marketing Start 1999-07-15

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 64764451
Hyphenated Format 64764-451

Supplemental Identifiers

RxCUI
261266 261267 261268 312440 312441 317573
UPC
0364764451240 0364764151041 0364764301149
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 actos (source: ndc)
Generic Name pioglitazone (source: ndc)
Application Number NDA021073 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 45 mg/1
source: ndc
Packaging
  • 6 CARTON in 1 TRAY (64764-451-02) / 1 BLISTER PACK in 1 CARTON / 7 TABLET in 1 BLISTER PACK
  • 30 TABLET in 1 BOTTLE (64764-451-24)
  • 90 TABLET in 1 BOTTLE (64764-451-25)
  • 500 TABLET in 1 BOTTLE (64764-451-26)
source: ndc

Packages (4)

Ingredients (1)

pioglitazone hydrochloride (45 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "20e43dff-4bf2-4ae7-82a1-e7e895123f93", "openfda": {"upc": ["0364764451240", "0364764151041", "0364764301149"], "unii": ["JQT35NPK6C"], "rxcui": ["261266", "261267", "261268", "312440", "312441", "317573"], "spl_set_id": ["d2ddc491-88a9-4063-9150-443b4fa4330c"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 CARTON in 1 TRAY (64764-451-02)  / 1 BLISTER PACK in 1 CARTON / 7 TABLET in 1 BLISTER PACK", "package_ndc": "64764-451-02", "marketing_start_date": "19990715"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (64764-451-24)", "package_ndc": "64764-451-24", "marketing_start_date": "19990715"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (64764-451-25)", "package_ndc": "64764-451-25", "marketing_start_date": "19990715"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (64764-451-26)", "package_ndc": "64764-451-26", "marketing_start_date": "19990715"}], "brand_name": "Actos", "product_id": "64764-451_20e43dff-4bf2-4ae7-82a1-e7e895123f93", "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": "64764-451", "generic_name": "pioglitazone", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Actos", "active_ingredients": [{"name": "PIOGLITAZONE HYDROCHLORIDE", "strength": "45 mg/1"}], "application_number": "NDA021073", "marketing_category": "NDA", "marketing_start_date": "19990715", "listing_expiration_date": "20261231"}