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ORLYNVAH

NDC 81153-100 · ITERUM THERAPEUTICS US LIMITED

Generic namesulopenem etzadroxil and probenecid

Dosage formTABLET, FILM COATED

RouteORAL

Active ingredient(s)SULOPENEM ETZADROXIL, PROBENECID

Strength500; 500 mg/1; mg/1

Marketing categoryNDA

Packages

81153-100-01 — 1 BOTTLE in 1 CARTON (81153-100-01) / 10 TABLET, FILM COATED in 1 BOTTLE

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

0527-1367 — Probenecid, 0591-5325 — Probenecid and Colchicine, 0591-5347 — Probenecid, 10135-541 — Probenecid, 16571-831 — Probenecid, 16571-832 — Probenecid and Colchicine, 50742-263 — Probenecid and Colchicine, 70518-4644 — Probenecid and Colchicine, 70518-4649 — Probenecid, 72162-2237 — Probenecid, 72162-2386 — Probenecid

From the FDA National Drug Code Directory, retrieved August 24, 2026. Product listings are submitted by labelers; FDA does not verify them.

Read from: FDA National Drug Code Directory, product.txt and package.txt (accessdata.fda.gov/cder/ndctext.zip) — Snapshot retrieved 2026-08-24, loaded 2026-08-24; CMS Medicare Part B Drug Average Sales Price (ASP) Pricing Files (cms.gov/medicare/payment/part-b-drugs/asp-pricing-files) -- the NDC-HCPCS crosswalk and Part B payment limit files — 2026 Q3 (July 2026 release). All data sources · How to read the labels