Hydrocodone Bitartrate And Homatropine Methylbromide
NDC Package 59741-262-16

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.

Hydrocodone Bitartrate And Homatropine Methylbromide is oral solution is indicated for the symptomatic relief of cough in adults and children 6 years of age and older. Marketed by Bio-pharm, Inc., this product is identified by NDC 59741-262 and is authorized under FDA application ANDA204765.

Identification & Billing

NDC Package Code
59741-262-16
Package Description
473 mL in 1 BOTTLE
Product Code
59741-262
11-Digit Billing Format
59741026216
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: 992668 - HYDROcodone bitartrate 5 MG / homatropine methylbromide 1.5 MG in 5 mL Oral Solution
  • RxCUI: 992668 - homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral Solution
  • RxCUI: 992668 - homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG per 5 ML Syrup

Clinical Specifications

Proprietary Name
Hydrocodone Bitartrate And Homatropine Methylbromide
Dosage Form
-
Usage Information
Hydrocodone bitartrate and Homatropine methylbromide oral solution is indicated for the symptomatic relief of cough in adults and children 6 years of age and older.

Regulatory & Marketing

Labeler Name
Bio-pharm, Inc.
FDA Application #
ANDA204765
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-07-2017
Listing Expiration
12-31-2020
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 59741-262-16 identifies a specific commercial package of 473 ml in 1 bottle of Hydrocodone Bitartrate And Homatropine Methylbromide, labeled by Bio-pharm, 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 Bio-pharm, Inc. on March 07, 2017. The current certification is valid through December 31, 2020.

How is this Bio-pharm, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59741026216. 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)
59741-262-16
11-Digit CMS (5-4-2)
59741-0262-16

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