Hydrocodone Bitartrate And Homatropine Methylbromide Syrup
NDC Package 40032-810-05

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Hydrocodone Bitartrate And Homatropine Methylbromide syrups is hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) is indicated for the symptomatic relief of cough in adults and children 6 years of age and older. This formulation utilizes a syrup delivery system. Marketed by Novel Laboratories, Inc., this product is identified by NDC 40032-810 and is authorized under FDA application ANDA203535.

Identification & Billing

NDC Package Code
40032-810-05
Package Description
473 mL in 1 BOTTLE
Product Code
40032-810
11-Digit Billing Format
40032081005
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
Non-Proprietary Name
Hydrocodone Bitartrate And Homatropine Methylbromide
Substance Name
Homatropine Methylbromide; Hydrocodone Bitartrate
Dosage Form
Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution (Syrup) is indicated for the symptomatic relief of cough in adults and children 6 years of age and older.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Novel Laboratories, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA203535
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-13-2017
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

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 40032-810-05 identifies a specific commercial package of 473 ml in 1 bottle of Hydrocodone Bitartrate And Homatropine Methylbromide, a human prescription drug labeled by Novel Laboratories, Inc.. This syrup 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 Novel Laboratories, Inc. on February 13, 2017. The current certification is valid through December 31, 2026.

How is this Novel Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 40032081005. 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)
40032-810-05
11-Digit CMS (5-4-2)
40032-0810-05

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