# ORLYNVAH

NDC: 81153-100
Generic name: sulopenem etzadroxil and probenecid
Labeler / Manufacturer: ITERUM THERAPEUTICS US LIMITED
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: New Drug Application (innovator)
Dosage form: TABLET, FILM COATED
Routes: ORAL
Marketing started: 20250701

FDA application: NDA213972

## Active ingredients

- PROBENECID: 500 mg/1
- SULOPENEM ETZADROXIL: 500 mg/1

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"81153-100"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=81153-100
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=24c451c0-4cfb-37f3-e063-6394a90a895e