Viva
NDC Package 54891-001-04

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Viva is • Temporarily relieves burning and irritation due to dryness of the eye.• Temporarily relieves discomfort due to minor irritations of the eye or to exposure to wind or sun.• Protects against further irritation or relieves dryness of the eye.• Lubricates to prevent further irritation or to relieve dryness of the eye. Marketed by Dakota Laboratories, Llc, this product is identified by NDC 54891-001 and is authorized under FDA application part349.

Identification & Billing

NDC Package Code
54891-001-04
Package Description
.5 mL in 1 VIAL, SINGLE-USE
Product Code
54891-001
11-Digit Billing Format
54891000104
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Viva
Dosage Form
-
Usage Information
• Temporarily relieves burning and irritation due to dryness of the eye.• Temporarily relieves discomfort due to minor irritations of the eye or to exposure to wind or sun.• Protects against further irritation or relieves dryness of the eye.• Lubricates to prevent further irritation or to relieve dryness of the eye.

Regulatory & Marketing

Labeler Name
Dakota Laboratories, Llc
FDA Application #
part349
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
02-19-1987
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (54891-001). Click a package code to view its specific billing and regulatory data.

54891-001-02
10 mL in 1 BOTTLE
54891-001-03
.5 mL in 1 VIAL, SINGLE-USE

* 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 54891-001-04 identifies a specific commercial package of .5 ml in 1 vial, single-use of Viva, labeled by Dakota Laboratories, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 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 Dakota Laboratories, Llc on February 19, 1987. The current certification is valid through December 31, 2017.

How is this Dakota Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54891000104. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (5-3-2)
54891-001-04
11-Digit CMS (5-4-2)
54891-0001-04

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