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United States · US · US:64764-158_271ff8ce-9ae5-4b65-8581-7ced42f47f2f
Actoplus Met
Orange BookUNIISPLATC A10BA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTakeda Pharmaceuticals America, Inc.
CountryUS (United States)
ATC codeA10BA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116476415818180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-158-18)
- ndc1164764158414 CARTON in 1 TRAY (64764-158-41) / 1 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED in 1 BLISTER PACK
- ndc11647641586060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-158-60)
Annotations
UNII (FDA Substance ID)
786Z46389E
METFORMIN HYDROCHLORIDE
RxCUI 235743
Orange Book
N021842
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "786Z46389E",
"rxcui": "235743",
"inchikey": "OETHQSJEHLVLGH-UHFFFAOYSA-N",
"display_name": "METFORMIN HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"42e49120-6f3f-11db-9fe1-0800200c9a66": {
"match": "brand_token",
"title": "ACTOPLUS MET (PIOGLITAZONE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
"spl_version": "27",
"published_date": "2025-04-07"
}
},
"productid": "64764-158_271ff8ce-9ae5-4b65-8581-7ced42f47f2f",
"productndc": "64764-158",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "021842",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "500MG;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "001",
"approval_date": "Aug 29, 2005"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "850MG;EQ 15MG BASE",
"product_no": "002",
"approval_date": "Aug 29, 2005"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE",
"proprietary_name": "Actoplus Met",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA021842",
"marketing_category": "NDA",
"nonproprietary_name": "pioglitazone and metformin hydrochloride",
"start_marketing_date": "20050829",
"active_numerator_strength": "850; 15"
}Related drugs
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