🇺🇸
United States · US · US:60505-3659_15cfffcf-3241-3e53-1f1e-ad300900662e
Sitagliptin and Metformin Hydrochloride
Orange BookUNIISPLATC A10BA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerApotex Corp.
CountryUS (United States)
ATC codeA10BA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11605053659660 TABLET, FILM COATED in 1 BOTTLE (60505-3659-6)
- ndc116050536597180 TABLET, FILM COATED in 1 BOTTLE (60505-3659-7)
Annotations
UNII (FDA Substance ID)
786Z46389E
METFORMIN HYDROCHLORIDE
RxCUI 235743
Orange Book
A202426
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": {
"5fa5aa67-455e-4ac6-864d-268a91286432": {
"match": "brand_token",
"title": "SITAGLIPTIN TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.]",
"spl_version": "1",
"published_date": "2026-06-01"
}
},
"productid": "60505-3659_15cfffcf-3241-3e53-1f1e-ad300900662e",
"productndc": "60505-3659",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "202426",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG;EQ 50MG BASE",
"product_no": "001",
"approval_date": "Apr 30, 2026"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1GM;EQ 50MG BASE",
"product_no": "002",
"approval_date": "Apr 30, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE",
"proprietary_name": "Sitagliptin and Metformin Hydrochloride",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA202426",
"marketing_category": "ANDA",
"nonproprietary_name": "Sitagliptin and Metformin Hydrochloride",
"start_marketing_date": "20260528",
"active_numerator_strength": "1000; 50"
}Related drugs
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