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United States · US · US:70710-1240_1686e1de-8172-444b-a267-ad3bc7ca69f1
ZITUVIO
Orange BookUNIISPLATC A10BH01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals (USA) Inc.
CountryUS (United States)
ATC codeA10BH01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11707101240330 TABLET in 1 BOTTLE (70710-1240-3)
- ndc11707101240990 TABLET in 1 BOTTLE (70710-1240-9)
Annotations
UNII (FDA Substance ID)
QFP0P1DV7Z
SITAGLIPTIN
RxCUI 593411
Orange Book
N211566
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "QFP0P1DV7Z",
"rxcui": "593411",
"inchikey": "MFFMDFFZMYYVKS-SECBINFHSA-N",
"display_name": "SITAGLIPTIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"b2da9d77-154b-48f7-8793-3f4a24dfafc6": {
"match": "brand_token",
"title": "ZITUVIO (SITAGLIPTIN) TABLET [ZYDUS LIFESCIENCES LIMITED]",
"spl_version": "6",
"published_date": "2025-02-03"
}
},
"productid": "70710-1240_1686e1de-8172-444b-a267-ad3bc7ca69f1",
"productndc": "70710-1240",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211566",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "25MG",
"product_no": "001",
"approval_date": "Oct 18, 2023"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "50MG",
"product_no": "002",
"approval_date": "Oct 18, 2023"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MG",
"product_no": "003",
"approval_date": "Oct 18, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SITAGLIPTIN",
"proprietary_name": "ZITUVIO",
"active_ingred_unit": "mg/1",
"application_number": "NDA211566",
"marketing_category": "NDA",
"nonproprietary_name": "Sitagliptin",
"start_marketing_date": "20231130",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code A10BH01.
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