Hydrocodone Bitartrate And Homatropine Methylbromide Solution
NDC Package 64950-371-47

11-digit billing NDC: 64950037147 · Billing unit: ML · 473 ML per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Hydrocodone Bitartrate And Homatropine Methylbromide solution is hydrocodone bitartrate and homatropine methylbromide is indicated for the symptomatic relief of cough in adult patients 18 years of age and older.Limitations of Use:Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)].Contraindicated in pediatric patients less than 6 years of age [see Contraindications (4)].Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of cough. This formulation utilizes a solution delivery system. Marketed by Genus Lifesciences Inc., this product is identified by NDC 64950-371 and is authorized under FDA application NDA005213.

Identification & Billing

NDC Package Code
64950-371-47
Package Description
473 mL in 1 BOTTLE
Product Code
64950-371
11-Digit Billing Format
64950037147
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: 992656 - HYDROcodone bitartrate 5 MG / homatropine methylbromide 1.5 MG Oral Tablet
  • RxCUI: 992656 - homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG Oral Tablet
  • 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
Non-Proprietary Name
Hydrocodone Bitartrate And Homatropine Methylbromide
Substance Name
Hydrocodone Bitartrate; Homatropine Methylbromide
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Hydrocodone bitartrate and homatropine methylbromide is indicated for the symptomatic relief of cough in adult patients 18 years of age and older.Limitations of Use:Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)].Contraindicated in pediatric patients less than 6 years of age [see Contraindications (4)].Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of cough.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Genus Lifesciences Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA005213
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
08-10-2022
Listing Expiration
12-31-2027
Exclude Flag
N
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 64950-371-47 identifies a specific commercial package of 473 ml in 1 bottle of Hydrocodone Bitartrate And Homatropine Methylbromide, a human prescription drug labeled by Genus Lifesciences Inc.. This solution is formulated for oral use and contains hydrocodone bitartrate; homatropine methylbromide as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Genus Lifesciences Inc. on August 10, 2022. The current certification is valid through December 31, 2027.

How is this Genus Lifesciences Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64950037147. 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)
64950-371-47
11-Digit CMS (5-4-2)
64950-0371-47

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