🇺🇸
United States · US · US:0781-5768_dd07ef38-4a9b-46f4-90ed-dd520cc1d75e
Sitagliptin Phosphate
Orange BookUNIISPLATC A10BH01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSandoz Inc
CountryUS (United States)
ATC codeA10BH01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11078157683130 TABLET, FILM COATED in 1 BOTTLE (0781-5768-31)
- ndc11078157689290 TABLET, FILM COATED in 1 BOTTLE (0781-5768-92)
Annotations
UNII (FDA Substance ID)
TS63EW8X6F
SITAGLIPTIN PHOSPHATE
RxCUI 621590
Orange Book
A202387
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "TS63EW8X6F",
"rxcui": "621590",
"inchikey": "GQPYTJVDPQTBQC-KLQYNRQASA-N",
"display_name": "SITAGLIPTIN PHOSPHATE",
"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": "0781-5768_dd07ef38-4a9b-46f4-90ed-dd520cc1d75e",
"productndc": "0781-5768",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "202387",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "001",
"approval_date": "Jan 14, 2026"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 50MG BASE",
"product_no": "002",
"approval_date": "Jan 14, 2026"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "003",
"approval_date": "Jan 14, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SITAGLIPTIN PHOSPHATE",
"proprietary_name": "Sitagliptin Phosphate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA202387",
"marketing_category": "ANDA",
"nonproprietary_name": "Sitagliptin Phosphate",
"start_marketing_date": "20260114",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code A10BH01.
Access this data programmatically
Query Sitagliptin Phosphate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.