NDC Package 0054-0449-49 Posaconazole

Suspension Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information
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:

0054-0449-49

Package Description:

1 BOTTLE, GLASS in 1 CARTON / 105 mL in 1 BOTTLE, GLASS

Product Code:

0054-0449

Proprietary Name:

Posaconazole

Non-Proprietary Name:

Posaconazole

Substance Name:

Posaconazole

Usage Information:

Posaconazole is used to prevent certain fungal infections in patients who have severely weakened immune systems (such as patients who have had chemotherapy). It belongs to a class of drugs known as azole antifungals. It works by stopping the growth of fungi.

11-Digit NDC Billing Format:

00054044949

Billing Unit:

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

NDC to RxNorm Crosswalk:

RxCUI: 665019 - posaconazole 200 MG in 5 mL Oral Suspension

RxCUI: 665019 - posaconazole 40 MG/ML Oral Suspension

RxCUI: 665019 - posaconazole 200 MG per 5 ML Oral Suspension

Product Type:

Human Prescription Drug

Labeler Name:

Hikma Pharmaceuticals Usa Inc.

Dosage Form:

Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

Administration Route(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

POSACONAZOLE 40 mg/mL

Pharmacologic Class(es):

Azole Antifungal - [EPC] (Established Pharmacologic Class)

Azoles - [CS]

Sample Package:

FDA Application Number:

ANDA208773

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

03-29-2023

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

0054 - Hikma Pharmaceuticals Usa Inc.
- 0054-0449 - Posaconazole
  - 0054-0449-49 - 1 BOTTLE, GLASS in 1 CARTON / 105 mL in 1 BOTTLE, GLASS

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 0054-0449-49?

The NDC Packaged Code 0054-0449-49 is assigned to a package of 1 bottle, glass in 1 carton / 105 ml in 1 bottle, glass of Posaconazole, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. The product's dosage form is suspension and is administered via oral form.

Is NDC 0054-0449 included in the NDC Directory?

Yes, Posaconazole with product code 0054-0449 is active and included in the NDC Directory. The product was first marketed by Hikma Pharmaceuticals Usa Inc. on March 29, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0054-0449-49?

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 0054-0449-49?

The 11-digit format is 00054044949. 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 4-4-2 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
4-4-2	0054-0449-49	5-4-2	00054-0449-49

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