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  5. NDC Package Code: 50458-603-28 Risperidone M-tab

NDC Package 50458-603-28 Risperidone M-tab

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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:
50458-603-28
Package Description:
7 BLISTER PACK in 1 BOX / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Product Code:
50458-603
Proprietary Name:
Risperidone M-tab
Usage Information:
Risperidone Tablets, Oral Solution, or Orally Disintegrating Tablets are contraindicated in patients with a known hypersensitivity to either risperidone or paliperidone, or to any of the excipients in the Risperidone Tablets, Oral Solution, or Orally Disintegrating Tablets formulations. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. Paliperidone is a metabolite of risperidone.
11-Digit NDC Billing Format:
50458060328
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
7 EA
NDC to RxNorm Crosswalk:
Labeler Name:
Janssen Pharmaceutical, Inc.
Sample Package:
No
FDA Application Number:
NDA021444
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
04-02-2003
End Marketing Date:
03-31-2018
Listing Expiration Date:
03-31-2018
Exclude Flag:
D
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 50458-603-28?

The NDC Packaged Code 50458-603-28 is assigned to a package of 7 blister pack in 1 box / 4 tablet, orally disintegrating in 1 blister pack of Risperidone M-tab, labeled by Janssen Pharmaceutical, Inc.. The product's dosage form is and is administered via form.

Is NDC 50458-603 included in the NDC Directory?

No, Risperidone M-tab with product code 50458-603 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Janssen Pharmaceutical, Inc. on April 02, 2003 and its listing in the NDC Directory is set to expire on March 31, 2018 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 50458-603-28?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 7.

What is the 11-digit format for NDC 50458-603-28?

The 11-digit format is 50458060328. 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
5-3-250458-603-285-4-250458-0603-28