🇺🇸
United States · US · US:0480-2607_ab518e96-e35b-40b1-b7e8-b4e01ada32eb
Sitagliptin
Orange BookUNIISPLATC A10BH01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA10BH01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11048026075630 TABLET, FILM COATED in 1 BOTTLE (0480-2607-56)
- ndc11048026079890 TABLET, FILM COATED in 1 BOTTLE (0480-2607-98)
Annotations
UNII (FDA Substance ID)
TS63EW8X6F
SITAGLIPTIN PHOSPHATE
RxCUI 621590
Orange Book
A202327
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": "0480-2607_ab518e96-e35b-40b1-b7e8-b4e01ada32eb",
"productndc": "0480-2607",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "202327",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "001",
"approval_date": "Dec 30, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 50MG BASE",
"product_no": "002",
"approval_date": "Dec 30, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "003",
"approval_date": "Dec 30, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SITAGLIPTIN PHOSPHATE",
"proprietary_name": "Sitagliptin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA202327",
"marketing_category": "ANDA",
"nonproprietary_name": "Sitagliptin",
"start_marketing_date": "20260528",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code A10BH01.
Access this data programmatically
Query Sitagliptin 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.