Balamine
NDC Package 63162-508-16

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.

Balamine is do not exceed 6 doses in a 24 hour period adults and children 12 years and over  2 teaspoonsful (10 mL) every 4 hours  children 6 years to under 12 years 1 teaspoonful (5 mL) every 4 hours children 2 years to under 6 years 1/2 teaspoonful (2.5 mL) every 4 hours children under 2 years ask a doctor. Marketed by Ballay Pharmaceuticals, Inc., this product is identified by NDC 63162-508 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
63162-508-16
Package Description
473 mL in 1 BOTTLE
Product Code
63162-508
11-Digit Billing Format
63162050816
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML
RxNorm Crosswalk
  • RxCUI: 1363752 - chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 5 mL Oral Solution
  • RxCUI: 1363752 - chlorpheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution
  • RxCUI: 1363752 - chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Balamine Dm Syrup
Dosage Form
-
Usage Information
Do not exceed 6 doses in a 24 hour period adults and children 12 years and over  2 teaspoonsful (10 mL) every 4 hours  children 6 years to under 12 years 1 teaspoonful (5 mL) every 4 hours children 2 years to under 6 years 1/2 teaspoonful (2.5 mL) every 4 hours children under 2 years ask a doctor

Regulatory & Marketing

Labeler Name
Ballay Pharmaceuticals, Inc.
FDA Application #
part341
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (63162-508). Click a package code to view its specific billing and regulatory data.

63162-508-20
6 BOTTLE in 1 TRAY / 20 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 63162-508-16 identifies a specific commercial package of 473 ml in 1 bottle of Balamine Dm Syrup, labeled by Ballay Pharmaceuticals, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 473 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 Ballay Pharmaceuticals, Inc. on April 23, 2013. The current certification is valid through December 31, 2017.

How is this Ballay Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63162050816. 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 (5-3-2)
63162-508-16
11-Digit CMS (5-4-2)
63162-0508-16

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