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United States · US · US:50090-5547_1325f170-4498-4996-ba8f-617f081b318e
JANUVIA
Orange BookUNIISPLATC A10BH01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeA10BH01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11500905547030 TABLET, FILM COATED in 1 BOTTLE (50090-5547-0)
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": "50090-5547_1325f170-4498-4996-ba8f-617f081b318e",
"productndc": "50090-5547",
"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": "25"
}Related drugs
Other records sharing ATC code A10BH01.
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