Tramadol Hydrochloride
NDC Package 68134-402-40

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Tramadol Hydrochloride is oral solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Marketed by Palmetto Pharmaceuticals, Inc., this product is identified by NDC 68134-402 and is authorized under FDA application NDA214044.

Identification & Billing

NDC Package Code
68134-402-40
Package Description
4 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68134-402-05)
Product Code
68134-402
11-Digit Billing Format
68134040240
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tramadol Hydrochloride
Dosage Form
-
Usage Information
Tramadol hydrochloride oral solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Regulatory & Marketing

Labeler Name
Palmetto Pharmaceuticals, Inc.
FDA Application #
NDA214044
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
09-11-2020
Listing Expiration
12-31-2025
Exclude Flag
I
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 68134-402-40 identifies a specific commercial package of 4 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 ml in 1 cup, unit-dose (68134-402-05) of Tramadol Hydrochloride, labeled by Palmetto Pharmaceuticals, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Palmetto Pharmaceuticals, Inc. on September 11, 2020. The current certification is valid through December 31, 2025.

How is this Palmetto Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68134040240. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
68134-402-40
11-Digit CMS (5-4-2)
68134-0402-40

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