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  5. NDC Package Code: 81153-100-01 Orlynvah

NDC Package 81153-100-01 Orlynvah

Sulopenem Etzadroxil And Probenecid Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
81153-100-01
Package Description:
1 BOTTLE in 1 CARTON / 10 TABLET, FILM COATED in 1 BOTTLE
Product Code:
81153-100
Proprietary Name:
Orlynvah
Non-Proprietary Name:
Sulopenem Etzadroxil And Probenecid
Substance Name:
Probenecid; Sulopenem Etzadroxil
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)] 
11-Digit NDC Billing Format:
81153010001
NDC to 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
Product Type:
Human Prescription Drug
Labeler Name:
Iterum Therapeutics Us Limited
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(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
Sample Package:
No
FDA Application Number:
NDA213972
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
07-01-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 81153-100-01?

The NDC Packaged Code 81153-100-01 is assigned to a 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. The product's dosage form is tablet, film coated and is administered via oral form.

Is NDC 81153-100 included in the NDC Directory?

Yes, Orlynvah with product code 81153-100 is active and included in the NDC Directory. The product was first marketed by Iterum Therapeutics Us Limited on July 01, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 81153-100-01?

The 11-digit format is 81153010001. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-281153-100-015-4-281153-0100-01