NDC Package 83831-105-01 Posfrea

Palonosetron Injection, Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Package Information
NDC HCPCS Crosswalk
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:

83831-105-01

Package Description:

1 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE

Product Code:

83831-105

Proprietary Name:

Posfrea

Non-Proprietary Name:

Palonosetron

Substance Name:

Palonosetron Hydrochloride

Usage Information:

POSFREA is contraindicated in patients known to have hypersensitivity to the drug or any of its components [see Adverse Reactions (6.2)].

11-Digit NDC Billing Format:

83831010501

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to RxNorm Crosswalk:

RxCUI: 1728050 - palonosetron 0.075 MG in 1.5 ML Injection
RxCUI: 1728050 - 1.5 ML palonosetron 0.05 MG/ML Injection
RxCUI: 1728050 - palonosetron 0.075 MG per 1.5 ML Injection
RxCUI: 1728055 - palonosetron 0.25 MG in 5 ML Injection
RxCUI: 1728055 - 5 ML palonosetron 0.05 MG/ML Injection

Product Type:

Human Prescription Drug

Labeler Name:

Avyxa Pharma, Llc

Dosage Form:

Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.

Administration Route(s):

Intravenous - Administration within or into a vein or veins.

Active Ingredient(s):

PALONOSETRON HYDROCHLORIDE .25 mg/5mL

Pharmacologic Class(es):

Sample Package:

FDA Application Number:

NDA203050

Marketing Category:

NDA - A product marketed under an approved New Drug Application.

Start Marketing Date:

09-30-2024

Listing Expiration Date:

12-31-2026

Exclude Flag:

Code Structure:

83831 - Avyxa Pharma, Llc
- 83831-105 - Posfrea
  - 83831-105-01 - 1 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE

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.

NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 83831-105-01 HCPCS crosswalk information with package details and bill units information.

NDC Billing Code	HCPCS Code	HCPCS Code Desc.	Dosage	Package Size	Package Quantity	Billable Units	Billable Units / Pkg
83831010501	J2468	Inj, palonosetron (posfrea)	25 MCG	5	1	10	10

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 83831-105-01?

The NDC Packaged Code 83831-105-01 is assigned to a package of 1 vial, single-dose in 1 carton / 5 ml in 1 vial, single-dose of Posfrea, a human prescription drug labeled by Avyxa Pharma, Llc. The product's dosage form is injection, solution and is administered via intravenous form.

Is NDC 83831-105 included in the NDC Directory?

Yes, Posfrea with product code 83831-105 is active and included in the NDC Directory. The product was first marketed by Avyxa Pharma, Llc on September 30, 2024 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 NDC billing unit for package 83831-105-01?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 83831-105-01?

The 11-digit format is 83831010501. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	83831-105-01	5-4-2	83831-0105-01

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