Bicaruvas
NDC Package 69728-0002-1

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.

Bicaruvas is .Adult and children 12 years older dissolve one packet in 1/2 glass of water every 4 hours or as directed by your doctor. Marketed by Prosana Distribuciones, S.a. De C.v., this product is identified by NDC 69728-0002 and is authorized under FDA application part331.

Identification & Billing

NDC Package Code
69728-0002-1
Package Description
118 mL in 1 PACKET
Product Code
69728-0002
11-Digit Billing Format
69728000201

Clinical Specifications

Proprietary Name
Bicaruvas
Dosage Form
-
Usage Information
.Adult and children 12 years older dissolve one packet in 1/2 glass of water every 4 hours or as directed by your doctor. Children under 12 years, consult a doctor

Regulatory & Marketing

Labeler Name
Prosana Distribuciones, S.a. De C.v.
FDA Application #
part331
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
04-23-2013
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 69728-0002-1 identifies a specific commercial package of 118 ml in 1 packet of Bicaruvas, labeled by Prosana Distribuciones, S.a. De C.v.. 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 Prosana Distribuciones, S.a. De C.v. on April 23, 2013. The current certification is valid through December 31, 2017.

How is this Prosana Distribuciones, S.a. De C.v. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69728000201. 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)
69728-0002-1
11-Digit CMS (5-4-2)
69728-0002-01

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