Actos

Orange BookUNIISPLATC A10BG03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerTakeda Pharmaceuticals America, Inc.

CountryUS (United States)

ATC codeA10BG03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6476445102
6 CARTON in 1 TRAY (64764-451-02) / 1 BLISTER PACK in 1 CARTON / 7 TABLET in 1 BLISTER PACK
ndc11
6476445124
30 TABLET in 1 BOTTLE (64764-451-24)
ndc11
6476445125
90 TABLET in 1 BOTTLE (64764-451-25)
ndc11
6476445126
500 TABLET in 1 BOTTLE (64764-451-26)

Annotations

UNII (FDA Substance ID)

JQT35NPK6C

PIOGLITAZONE HYDROCHLORIDE

RxCUI 259319

Orange Book

N021073

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "JQT35NPK6C",
    "rxcui": "259319",
    "inchikey": "GHUUBYQTCDQWRA-UHFFFAOYSA-N",
    "display_name": "PIOGLITAZONE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "d2ddc491-88a9-4063-9150-443b4fa4330c": {
      "match": "brand_token",
      "title": "ACTOS (PIOGLITAZONE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
      "spl_version": "20",
      "published_date": "2025-04-09"
    }
  },
  "productid": "64764-451_20e43dff-4bf2-4ae7-82a1-e7e895123f93",
  "productndc": "64764-451",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "021073",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 15MG BASE",
        "product_no": "001",
        "approval_date": "Jul 15, 1999"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 30MG BASE",
        "product_no": "002",
        "approval_date": "Jul 15, 1999"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 45MG BASE",
        "product_no": "003",
        "approval_date": "Jul 15, 1999"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PIOGLITAZONE HYDROCHLORIDE",
  "proprietary_name": "Actos",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021073",
  "marketing_category": "NDA",
  "nonproprietary_name": "pioglitazone",
  "start_marketing_date": "19990715",
  "active_numerator_strength": "45"
}

Related drugs

Other records sharing ATC code A10BG03.

Access this data programmatically

Query Actos and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs