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United States · US · US:0173-0922_1cb00eb0-9123-4532-b49e-55b9265daf9e
Blujepa
Orange BookUNIISPLATC J01XX13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlaxoSmithKline LLC
CountryUS (United States)
ATC codeJ01XX13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1101730922388 TABLET, FILM COATED in 1 BOTTLE (0173-0922-38)
- ndc11017309224520 TABLET, FILM COATED in 1 BOTTLE (0173-0922-45)
Annotations
UNII (FDA Substance ID)
5P7X0H2O6B
GEPOTIDACIN MESYLATE
Orange Book
N218230
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "5P7X0H2O6B",
"rxcui": null,
"inchikey": "MTLHHQWYERWLIX-RGFWRHHQSA-N",
"display_name": "GEPOTIDACIN MESYLATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"80b57cfe-7819-4d95-a57d-014af42f118d": {
"match": "brand_token",
"title": "BLUJEPA (GEPOTIDACIN) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]",
"spl_version": "3",
"published_date": "2026-02-23"
}
},
"productid": "0173-0922_1cb00eb0-9123-4532-b49e-55b9265daf9e",
"productndc": "0173-0922",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "218230",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 750MG BASE",
"product_no": "001",
"approval_date": "Mar 25, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GEPOTIDACIN MESYLATE",
"proprietary_name": "Blujepa",
"active_ingred_unit": "mg/1",
"application_number": "NDA218230",
"marketing_category": "NDA",
"nonproprietary_name": "gepotidacin",
"start_marketing_date": "20250325",
"active_numerator_strength": "750"
}Access this data programmatically
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