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United States · US · US:73336-075_6744a1cf-7abb-4623-85e3-8f67a9eb19d4
GEMTESA
Orange BookUNIISPLATC G04BD15
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSumitomo Pharma America, Inc.
CountryUS (United States)
ATC codeG04BD15
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1173336075071 BOTTLE in 1 CARTON (73336-075-07) / 7 TABLET, FILM COATED in 1 BOTTLE
- ndc11733360753030 TABLET, FILM COATED in 1 BOTTLE (73336-075-30)
- ndc11733360759090 TABLET, FILM COATED in 1 BOTTLE (73336-075-90)
Annotations
UNII (FDA Substance ID)
M5TSE03W5U
VIBEGRON
RxCUI 2472254
Orange Book
N213006
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "M5TSE03W5U",
"rxcui": "2472254",
"inchikey": "DJXRIQMCROIRCZ-XOEOCAAJSA-N",
"display_name": "VIBEGRON",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"25f21d25-14f8-4fda-91f6-7aa8b68aa1c8": {
"match": "brand_token",
"title": "GEMTESA (VIBEGRON) TABLET, FILM COATED [SUMITOMO PHARMA AMERICA, INC.\n]",
"spl_version": "12",
"published_date": "2025-04-09"
}
},
"productid": "73336-075_6744a1cf-7abb-4623-85e3-8f67a9eb19d4",
"productndc": "73336-075",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "213006",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "75MG",
"product_no": "001",
"approval_date": "Dec 23, 2020"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "VIBEGRON",
"proprietary_name": "GEMTESA",
"active_ingred_unit": "mg/1",
"application_number": "NDA213006",
"marketing_category": "NDA",
"nonproprietary_name": "vibegron",
"start_marketing_date": "20201229",
"active_numerator_strength": "75"
}Related drugs
Other records sharing ATC code G04BD15.
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