Vistide
NDC Package 61958-0101-1

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.

Vistide is initiation of therapy with VISTIDE is contraindicated in patients with a serum creatinine > 1.5 mg/dL, a calculated creatinine clearance ≤ 55 mL/min, or a urine protein ≥ 100 mg/dL (equivalent to ≥ 2+ proteinuria).VISTIDE is contraindicated in patients receiving agents with nephrotoxic potential. Marketed by Gilead Sciences, Inc., this product is identified by NDC 61958-0101 and is authorized under FDA application NDA020638.

Identification & Billing

NDC Package Code
61958-0101-1
Package Description
1 VIAL, SINGLE-USE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-USE
Product Code
61958-0101
11-Digit Billing Format
61958010101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Vistide
Dosage Form
-
Usage Information
Initiation of therapy with VISTIDE is contraindicated in patients with a serum creatinine > 1.5 mg/dL, a calculated creatinine clearance ≤ 55 mL/min, or a urine protein ≥ 100 mg/dL (equivalent to ≥ 2+ proteinuria).VISTIDE is contraindicated in patients receiving agents with nephrotoxic potential. Such agents must be discontinued at least seven days prior to starting therapy with VISTIDE.VISTIDE is contraindicated in patients with hypersensitivity to cidofovir.VISTIDE is contraindicated in patients with a history of clinically severe hypersensitivity to probenecid or other sulfa-containing medications.Direct intraocular injection of VISTIDE is contraindicated; direct injection of cidofovir has been associated with iritis, ocular hypotony, and permanent impairment of vision.

Regulatory & Marketing

Labeler Name
Gilead Sciences, Inc.
FDA Application #
NDA020638
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-26-1996
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.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 61958-0101-1 identifies a specific commercial package of 1 vial, single-use in 1 carton / 5 ml in 1 vial, single-use of Vistide, labeled by Gilead Sciences, Inc.. 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 Gilead Sciences, Inc. on June 26, 1996. The current certification is valid through December 31, 2017.

How is this Gilead Sciences, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61958010101. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
61958-0101-1
11-Digit CMS (5-4-2)
61958-0101-01

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