Prescription drug · NDA
Orlynvah (Sulopenem etzadroxil and probenecid) NDC 81153-100
Sulopenem etzadroxil 500 mg/1; Probenecid 500 mg/1 · Tablet, Film coated · Oral · ITERUM THERAPEUTICS US LIMITED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81153-100-01 | 81153010001 | 1 BOTTLE in 1 CARTON (81153-100-01) / 10 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 1, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Orlynvah
- Generic name (nonproprietary)
- sulopenem etzadroxil and probenecid
- Active ingredients
- Sulopenem etzadroxil — 500 mg/1Probenecid — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- ITERUM THERAPEUTICS US LIMITEDNDC labeler code 81153
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213972
- Marketing start
- Listing expires
- Identifiers
- Product ID 81153-100_abcb22dd-7c10-4459-a98c-d03582b426a3SPL ID abcb22dd-7c10-4459-a98c-d03582b426a3SPL set ID 24c451c0-4cfb-37f3-e063-6394a90a895eRxCUI 2717843, 2717850UNII 492M3I304T, PO572Z7917
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N481153010001followed by a unit qualifier and the quantityPackage 81153-0100-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
ORLYNVAH, a combination of sulopenem etzadroxil, a penem antibacterial, and probenecid, a renal tubular transport inhibitor, is indicated for the treatment of uncomplicated urinary tract infections (uUTI) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. ( 1.1 ) Limitations of Use ORLYNVAH is not indicated for the treatment of: Complicated urinary tract infections (cUTI) or as step-down treatment after intravenous antibacterial treatment of cUTI. ( 1.1 , 14.2 ) Complicated intra-abdominal infections (cIAI) or as step-down treatment after intravenous anti…
Excerpt only. Read the full label for complete information.
About NDC 81153-100
- What is NDC 81153-100?
- 81153-100 is the product NDC for Orlynvah, Sulopenem etzadroxil 500 mg/1; Probenecid 500 mg/1 tablet, film coated, listed with the FDA by ITERUM THERAPEUTICS US LIMITED. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Orlynvah (Sulopenem etzadroxil and probenecid).
- What is the active ingredient?
- Sulopenem etzadroxil, Probenecid.
- Who is the labeler?
- ITERUM THERAPEUTICS US LIMITED, NDC labeler code 81153. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Orlynvah?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.