Hydrocodone Bitartrate And Homatropine Methylbromide Tablet
NDC Package 40032-118-03
Package Information
Hydrocodone Bitartrate And Homatropine Methylbromide tablets is uSP are indicated for the symptomatic relief of cough in adults and children 6 years of age and older. This formulation utilizes a tablet delivery system. Marketed by Novel Laboratories, Inc., this product is identified by NDC 40032-118 and is authorized under FDA application ANDA091528.
Identification & Billing
- 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
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 40032 - Novel Laboratories, Inc.
- 40032-118 - Hydrocodone Bitartrate And Homatropine Methylbromide
- 40032-118-03 - 30 TABLET in 1 BOTTLE
- 40032-118 - Hydrocodone Bitartrate And Homatropine Methylbromide
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 (40032-118). Click a package code to view its specific billing and regulatory data.
* 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 40032-118-03 identifies a specific commercial package of 30 tablet in 1 bottle of Hydrocodone Bitartrate And Homatropine Methylbromide, a human prescription drug labeled by Novel Laboratories, Inc.. This tablet 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 September 23, 2014. 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: 40032011803. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
