🇺🇸
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
- ndc11647643043030 TABLET in 1 BOTTLE (64764-304-30)
- ndc11647643049090 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"
}Related drugs
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