Promethazine Vc
NDC Package 0603-1587-58

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 discontinued by the firm.

Promethazine Vc is see also Warning section. Marketed by Par Pharmaceutical, this product is identified by NDC 0603-1587 and is authorized under FDA application ANDA040654.

Identification & Billing

NDC Package Code
0603-1587-58
Package Description
473 mL in 1 BOTTLE
Product Code
0603-1587
11-Digit Billing Format
00603158758
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML

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
Par Pharmaceutical
FDA Application #
ANDA040654
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-07-2006
End Marketing Date
10-31-2019
Listing Expiration
10-31-2019
Exclude Flag
D
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 (0603-1587). Click a package code to view its specific billing and regulatory data.

0603-1587-54
118 mL in 1 BOTTLE

* 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 0603-1587-58 identifies a specific commercial package of 473 ml in 1 bottle of Promethazine Vc, labeled by Par Pharmaceutical. 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 Par Pharmaceutical on December 07, 2006. The current certification is valid through October 31, 2019.

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 Par Pharmaceutical product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00603158758. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 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 (4-4-2)
0603-1587-58
11-Digit CMS (5-4-2)
00603-1587-58

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