🇺🇸
United States · US · US:65862-526_1468f2ff-4355-402a-8c46-0b9272ae633e
Pioglitazone Hydrochloride and Metformin Hydrochloride
Orange BookUNIISPLATC A10BA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeA10BA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116586252618180 TABLET, FILM COATED in 1 BOTTLE (65862-526-18)
- ndc11658625266060 TABLET, FILM COATED in 1 BOTTLE (65862-526-60)
Annotations
UNII (FDA Substance ID)
786Z46389E
METFORMIN HYDROCHLORIDE
RxCUI 235743
Orange Book
A200823
ABAB
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": {
"6cd7c8b7-f5d4-423b-ae9f-86541869d8cf": {
"match": "brand_token",
"title": "PIOGLITAZONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]",
"spl_version": "5",
"published_date": "2026-03-26"
}
},
"productid": "65862-526_1468f2ff-4355-402a-8c46-0b9272ae633e",
"productndc": "65862-526",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "200823",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG;EQ 15MG BASE",
"product_no": "001",
"approval_date": "Feb 13, 2013"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "850MG;EQ 15MG BASE",
"product_no": "002",
"approval_date": "Feb 13, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE",
"proprietary_name": "Pioglitazone Hydrochloride and Metformin Hydrochloride",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA200823",
"marketing_category": "ANDA",
"nonproprietary_name": "Pioglitazone Hydrochloride and Metformin Hydrochloride",
"start_marketing_date": "20130213",
"active_numerator_strength": "850; 15"
}Related drugs
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