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United States · US · US:64764-304_23f68487-5d22-4618-9ccc-417aeb9fd3a8

Duetact

Orange BookUNIISPLATC A10BB

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerTakeda Pharmaceuticals America, Inc.
CountryUS (United States)
ATC codeA10BB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6476430430
    30 TABLET in 1 BOTTLE (64764-304-30)
  • ndc11
    6476430490
    90 TABLET in 1 BOTTLE (64764-304-90)

Annotations

UNII (FDA Substance ID)
6KY687524K
GLIMEPIRIDE
RxCUI 25789
Orange Book
N021925
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "6KY687524K",
    "rxcui": "25789",
    "inchikey": "WIGIZIANZCJQQY-RUCARUNLSA-N",
    "display_name": "GLIMEPIRIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f8b0c917-3fdd-4a28-a47d-6225b8195458": {
      "match": "brand_token",
      "title": "DUETACT (PIOGLITAZONE AND GLIMEPIRIDE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
      "spl_version": "23",
      "published_date": "2025-04-09"
    }
  },
  "productid": "64764-304_23f68487-5d22-4618-9ccc-417aeb9fd3a8",
  "productndc": "64764-304",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "021925",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "2MG;30MG",
        "product_no": "001",
        "approval_date": "Jul 28, 2006"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "4MG;30MG",
        "product_no": "002",
        "approval_date": "Jul 28, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE",
  "proprietary_name": "Duetact",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA021925",
  "marketing_category": "NDA",
  "nonproprietary_name": "pioglitazone and glimepiride",
  "start_marketing_date": "20060728",
  "active_numerator_strength": "4; 30"
}

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