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United States · US · US:81153-100_abcb22dd-7c10-4459-a98c-d03582b426a3
ORLYNVAH
Orange BookUNIISPLATC M04AB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerITERUM THERAPEUTICS US LIMITED
CountryUS (United States)
ATC codeM04AB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1181153100011 BOTTLE in 1 CARTON (81153-100-01) / 10 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
PO572Z7917
PROBENECID
RxCUI 8698
Orange Book
N213972
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "PO572Z7917",
"rxcui": "8698",
"inchikey": "DBABZHXKTCFAPX-UHFFFAOYSA-N",
"display_name": "PROBENECID",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"24c451c0-4cfb-37f3-e063-6394a90a895e": {
"match": "brand_token",
"title": "ORLYNVAH (SULOPENEM ETZADROXIL AND PROBENECID) TABLET, FILM COATED [ITERUM THERAPEUTICS US LIMITED]",
"spl_version": "6",
"published_date": "2026-02-09"
}
},
"productid": "81153-100_abcb22dd-7c10-4459-a98c-d03582b426a3",
"productndc": "81153-100",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "213972",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "500MG;500MG",
"product_no": "001",
"approval_date": "Oct 25, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PROBENECID; SULOPENEM ETZADROXIL",
"proprietary_name": "ORLYNVAH",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA213972",
"marketing_category": "NDA",
"nonproprietary_name": "sulopenem etzadroxil and probenecid",
"start_marketing_date": "20250701",
"active_numerator_strength": "500; 500"
}Access this data programmatically
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