Prevpac
NDC Package 54868-4909-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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 inactivated by the FDA.

Prevpac is contraindicated in patients with known severe hypersensitivity to any component of the formulation of PREVACID.A history of allergic reaction to any of the penicillins is a contraindication.Clarithromycin is contraindicated in patients with a known hypersensitivity to clarithromycin, erythromycin, or any of the macrolide antibiotics.Concomitant administration of PREVPAC and any of the following drugs is contraindicated: cisapride, pimozide, astemizole, terfenadine, ergotamine or dihydroergotamine (see Drug Interactions). Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-4909 and is authorized under FDA application NDA050757.

Identification & Billing

NDC Package Code
54868-4909-0
Package Description
14 BLISTER PACK in 1 BOX / 1 KIT in 1 BLISTER PACK
Product Code
54868-4909
11-Digit Billing Format
54868490900
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
14 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Prevpac
Dosage Form
-
Usage Information
PREVPAC is contraindicated in patients with known severe hypersensitivity to any component of the formulation of PREVACID.A history of allergic reaction to any of the penicillins is a contraindication.Clarithromycin is contraindicated in patients with a known hypersensitivity to clarithromycin, erythromycin, or any of the macrolide antibiotics.Concomitant administration of PREVPAC and any of the following drugs is contraindicated: cisapride, pimozide, astemizole, terfenadine, ergotamine or dihydroergotamine (see Drug Interactions). There have been post-marketing reports of drug interactions when clarithromycin and/or erythromycin are co-administered with cisapride, pimozide, astemizole, or terfenadine resulting in cardiac arrhythmias (QT prolongation, ventricular tachycardia, ventricular fibrillation, and torsades de pointes) most likely due to inhibition of metabolism of these drugs by erythromycin and clarithromycin. Fatalities have been reported.For information about contraindications of other drugs that may be used in combination with amoxicillin or clarithromycin, refer to the CONTRAINDICATIONS section of their package inserts.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA050757
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-20-2005
Listing Expiration
12-31-2017
Exclude Flag
I
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 54868-4909-0 identifies a specific commercial package of 14 blister pack in 1 box / 1 kit in 1 blister pack of Prevpac, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 14 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Physicians Total Care, Inc. on May 20, 2005. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868490900. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 14 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 (5-4-1)
54868-4909-0
11-Digit CMS (5-4-2)
54868-4909-00

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