Promethazine Vc
NDC Package 54868-3935-0

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.

Promethazine Vc is see also Warning section. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-3935 and is authorized under FDA application ANDA040654.

Identification & Billing

NDC Package Code
54868-3935-0
Package Description
118 mL in 1 BOTTLE
Product Code
54868-3935
11-Digit Billing Format
54868393500
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
118 ML
RxNorm Crosswalk
  • RxCUI: 1248057 - phenylephrine HCl 5 MG / promethazine HCl 6.25 MG in 5 mL Oral Solution
  • RxCUI: 1248057 - phenylephrine hydrochloride 1 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution
  • RxCUI: 1248057 - phenylephrine hydrochloride 5 MG / promethazine hydrochloride 6.25 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Promethazine Vc
Dosage Form
-
Usage Information
See also Warning section. This combination medication is used to temporarily relieve symptoms caused by the common cold or allergies. Promethazine is an antihistamine that relieves watery eyes, itchy eyes/nose/throat, runny nose, and sneezing. Phenylephrine is a decongestant that helps relieve stuffy nose and ear congestion symptoms. Cough-and-cold products do not cure or shorten the length of the common cold and may cause serious side effects if not used properly. Ask your doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA040654
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-06-2000
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 54868-3935-0 identifies a specific commercial package of 118 ml in 1 bottle of Promethazine Vc, labeled by Physicians Total Care, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 118 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 September 06, 2000. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

See also Warning section. This combination medication is used to temporarily relieve symptoms caused by the common cold or allergies. Promethazine is an antihistamine that relieves watery eyes, itchy eyes/nose/throat, runny nose, and sneezing. Phenylephrine is a decongestant that helps relieve stuffy nose and ear congestion symptoms. Cough-and-cold products do not cure or shorten the length of the common cold and may cause serious side effects if not used properly. Ask your doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

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: 54868393500. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 118 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)
54868-3935-0
11-Digit CMS (5-4-2)
54868-3935-00

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