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United States · US · US:0006-5368_232103cc-9755-4194-867a-8679e263905a
STEGLUJAN
Orange BookUNIISPLATC A10BK
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMerck Sharp & Dohme LLC
CountryUS (United States)
ATC codeA10BK
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11000653680330 TABLET, FILM COATED in 1 BOTTLE (0006-5368-03)
- ndc11000653680690 TABLET, FILM COATED in 1 BOTTLE (0006-5368-06)
- ndc110006536807500 TABLET, FILM COATED in 1 BOTTLE (0006-5368-07)
- ndc1100065368092 BOTTLE in 1 CARTON (0006-5368-09) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5368-08)
Annotations
UNII (FDA Substance ID)
MLU731K321
ERTUGLIFLOZIN PIDOLATE
RxCUI 1992674
Orange Book
N209805
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "MLU731K321",
"rxcui": "1992674",
"inchikey": "YHIUPZFKHZTLSH-LXYIGGQGSA-N",
"display_name": "ERTUGLIFLOZIN PIDOLATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"c2c553d8-5a9d-4366-bf53-8bdb5a876d19": {
"match": "brand_token",
"title": "STEGLUJAN (ERTUGLIFLOZIN AND SITAGLIPTIN) TABLET, FILM COATED [MERCK SHARP & DOHME LLC]",
"spl_version": "23",
"published_date": "2025-01-13"
}
},
"productid": "0006-5368_232103cc-9755-4194-867a-8679e263905a",
"productndc": "0006-5368",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "209805",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "5MG;EQ 100MG BASE",
"product_no": "001",
"approval_date": "Dec 19, 2017"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "15MG;EQ 100MG BASE",
"product_no": "002",
"approval_date": "Dec 19, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ERTUGLIFLOZIN PIDOLATE; SITAGLIPTIN PHOSPHATE",
"proprietary_name": "STEGLUJAN",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA209805",
"marketing_category": "NDA",
"nonproprietary_name": "ertugliflozin and sitagliptin",
"start_marketing_date": "20171219",
"active_numerator_strength": "15; 100"
}Related drugs
Other records sharing ATC code A10BK.
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