Orlynvah Tablet, Film Coated
NDC Package 81153-100-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Orlynvah (sulopenem etzadroxil and probenecid) tablets is oRLYNVAH is contraindicated in patients with:A history of hypersensitivity to the components of ORLYNVAH (sulopenem etzadroxil and probenecid) or other beta-lactam antibacterial drugs [see Warnings and Precautions (5.1)]Known blood dyscrasias Known uric acid kidney stones [see Warnings and Precautions (5.3)]Concomitant use of ORLYNVAH and ketorolac tromethamine is contraindicated [see Drug Interactions (7.1)] . This formulation utilizes a tablet, film coated delivery system. Marketed by Iterum Therapeutics Us Limited, this product is identified by NDC 81153-100 and is authorized under FDA application NDA213972.

Identification & Billing

NDC Package Code
81153-100-01
Package Description
1 BOTTLE in 1 CARTON / 10 TABLET, FILM COATED in 1 BOTTLE
Product Code
81153-100
11-Digit Billing Format
81153010001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 2717843 - probenecid 500 MG / sulopenem etzadroxil 500 MG Oral Tablet
  • RxCUI: 2717850 - Orlynvah 500 MG / 500 MG Oral Tablet
  • RxCUI: 2717850 - probenecid 500 MG / sulopenem etzadroxil 500 MG Oral Tablet [Orlynvah]
  • RxCUI: 2717850 - Orlynvah (probenecid 500 MG / sulopenem etzadroxil 500 MG) Oral Tablet

Clinical Specifications

Proprietary Name
Orlynvah
Non-Proprietary Name
Sulopenem Etzadroxil And Probenecid
Substance Name
Probenecid; Sulopenem Etzadroxil
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Usage Information
ORLYNVAH is contraindicated in patients with:A history of hypersensitivity to the components of ORLYNVAH (sulopenem etzadroxil and probenecid) or other beta-lactam antibacterial drugs [see Warnings and Precautions (5.1)]Known blood dyscrasias Known uric acid kidney stones [see Warnings and Precautions (5.3)]Concomitant use of ORLYNVAH and ketorolac tromethamine is contraindicated [see Drug Interactions (7.1)] 

Regulatory & Marketing

Labeler Name
Iterum Therapeutics Us Limited
Product Type
Human Prescription Drug
FDA Application #
NDA213972
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-01-2025
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 81153-100-01 identifies a specific commercial package of 1 bottle in 1 carton / 10 tablet, film coated in 1 bottle of Orlynvah, a human prescription drug labeled by Iterum Therapeutics Us Limited. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This tablet, film coated is formulated for oral use and contains probenecid; sulopenem etzadroxil as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Iterum Therapeutics Us Limited on July 01, 2025. The current certification is valid through December 31, 2027.

How is this Iterum Therapeutics Us Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81153010001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
81153-100-01
11-Digit CMS (5-4-2)
81153-0100-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.