Trimethobenzamide Hydrochloride Injection
NDC Package 54288-158-25

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

Package Information

Trimethobenzamide Hydrochloride injection is indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis. This formulation utilizes a injection delivery system. Marketed by Bpi Labs, Llc, this product is identified by NDC 54288-158 and is authorized under FDA application ANDA219606.

Identification & Billing

NDC Package Code
54288-158-25
Package Description
25 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE
Product Code
54288-158
11-Digit Billing Format
54288015825

Clinical Specifications

Proprietary Name
Trimethobenzamide Hydrochloride
Non-Proprietary Name
Trimethobenzamide Hydrochloride
Substance Name
Trimethobenzamide Hydrochloride
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
TRIMETHOBENZAMIDE HYDROCHLORIDE 100 mg/mL
Pharmacologic Class
Usage Information
Trimethobenzamide Hydrochloride Injection is indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.

Regulatory & Marketing

Labeler Name
Bpi Labs, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA219606
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-01-2026
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 54288-158-25 identifies a specific commercial package of 25 vial, single-dose in 1 carton / 2 ml in 1 vial, single-dose of Trimethobenzamide Hydrochloride, a human prescription drug labeled by Bpi Labs, Llc. This injection is formulated for intramuscular use and contains trimethobenzamide hydrochloride 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 Bpi Labs, Llc on July 01, 2026. The current certification is valid through December 31, 2027.

How is this Bpi Labs, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54288015825. 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)
54288-158-25
11-Digit CMS (5-4-2)
54288-0158-25

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