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United States · US · US:55154-5040_f843c4d2-5112-42bf-b060-ed74648d922e
JANUVIA
Orange BookUNIISPLATC A10BH01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCardinal Health 107, LLC
CountryUS (United States)
ATC codeA10BH01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1155154504082340 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-5040-8)
Annotations
UNII (FDA Substance ID)
TS63EW8X6F
SITAGLIPTIN PHOSPHATE
RxCUI 621590
Orange Book
N021995
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": {
"9d558f96-24a5-4788-8933-38256c17384b": {
"match": "brand_token",
"title": "JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]",
"spl_version": "15",
"published_date": "2025-11-17"
}
},
"productid": "55154-5040_f843c4d2-5112-42bf-b060-ed74648d922e",
"productndc": "55154-5040",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "021995",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "001",
"approval_date": "Oct 16, 2006"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 50MG BASE",
"product_no": "002",
"approval_date": "Oct 16, 2006"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "003",
"approval_date": "Oct 16, 2006"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SITAGLIPTIN PHOSPHATE",
"proprietary_name": "JANUVIA",
"active_ingred_unit": "mg/1",
"application_number": "NDA021995",
"marketing_category": "NDA",
"nonproprietary_name": "sitagliptin",
"start_marketing_date": "20061016",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code A10BH01.
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