Hydromet Solution
NDC Package 0472-1030-16

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 approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Hydromet (hydrocodone bitartrate and homatropine methylbromide) solution is a medication used to relieve a dry cough usually caused by the common cold or other conditions as prescribed by your doctor. This formulation utilizes a solution delivery system. Marketed by Actavis Pharma, Inc., this product is identified by NDC 0472-1030 and is authorized under FDA application ANDA088017.

Identification & Billing

NDC Package Code
0472-1030-16
Package Description
473 mL in 1 BOTTLE
Product Code
0472-1030
11-Digit Billing Format
00472103016
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
  • RxCUI: 992675 - Hydromet 5 MG / 1.5 MG in 5 mL Oral Solution
  • RxCUI: 992675 - homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral Solution [Hydromet]

Clinical Specifications

Proprietary Name
Hydromet
Non-Proprietary Name
Hydrocodone Bitartrate And Homatropine Methylbromide
Substance Name
Homatropine Methylbromide; Hydrocodone Bitartrate
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
This medication is used to relieve a dry cough usually caused by the common cold or other conditions as prescribed by your doctor. Relieving a cough helps you get more rest and sleep. This product contains 2 medications, hydrocodone and homatropine. Hydrocodone is an opioid cough suppressant (antitussive) that works on certain centers in the brain to stop the urge to cough. Homatropine belongs to a class of drugs known as anticholinergics. This medication is generally used for short-term treatment. It should not be used for persistent coughs from smoking or long-term breathing problems (e.g., asthma, emphysema), or for coughs with a lot of mucus or fluids (productive coughs), unless directed by your doctor. Opioid cough suppressants should not be used in children younger than 18 years. Children are at higher risk for serious (even fatal) side effects, especially breathing problems. Talk with the doctor about the risks and benefits of this medication. Cough-and-cold products do not cure colds. Cough due to a common cold often does not need to be treated with medicine. 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.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Actavis Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA088017
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-30-2002
End Marketing Date
08-31-2026
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 0472-1030-16 identifies a specific commercial package of 473 ml in 1 bottle of Hydromet, a human prescription drug labeled by Actavis Pharma, Inc.. This solution is formulated for oral use and contains homatropine methylbromide; hydrocodone bitartrate 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 Actavis Pharma, Inc. on September 30, 2002.

What are the primary indications for this medication?

This medication is used to relieve a dry cough usually caused by the common cold or other conditions as prescribed by your doctor. Relieving a cough helps you get more rest and sleep. This product contains 2 medications, hydrocodone and homatropine. Hydrocodone is an opioid cough suppressant (antitussive) that works on certain centers in the brain to stop the urge to cough. Homatropine belongs to a class of drugs known as anticholinergics. This medication is generally used for short-term treatment. It should not be used for persistent coughs from smoking or long-term breathing problems (e.g., asthma, emphysema), or for coughs with a lot of mucus or fluids (productive coughs), unless directed by your doctor. Opioid cough suppressants should not be used in children younger than 18 years. Children are at higher risk for serious (even fatal) side effects, especially breathing problems. Talk with the doctor about the risks and benefits of this medication. Cough-and-cold products do not cure colds. Cough due to a common cold often does not need to be treated with medicine. 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 Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00472103016. 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)
0472-1030-16
11-Digit CMS (5-4-2)
00472-1030-16

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