Tramadol Hydrochloride And Acetaminophen Tablet, Film Coated
NDC Package 45865-170-60

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

Package Information

Tramadol Hydrochloride And Acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use:Tramadol hydrochlorideandacetaminophen tablets are indicated for short-term use of five days or less. This formulation utilizes a tablet, film coated delivery system. Marketed by Medsource Pharmaceuticals, this product is identified by NDC 45865-170 and is authorized under FDA application ANDA207152.

Identification & Billing

NDC Package Code
45865-170-60
Package Description
60 TABLET, FILM COATED in 1 BOTTLE
Product Code
45865-170
11-Digit Billing Format
45865017060
RxNorm Crosswalk
  • RxCUI: 836395 - traMADol HCl 37.5 MG / acetaminophen 325 MG Oral Tablet
  • RxCUI: 836395 - acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet
  • RxCUI: 836395 - APAP 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet

Clinical Specifications

Proprietary Name
Tramadol Hydrochloride And Acetaminophen
Non-Proprietary Name
Tramadol Hydrochloride And Acetaminophen
Substance Name
Acetaminophen; Tramadol Hydrochloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use:Tramadol hydrochlorideandacetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or  duration [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): Have not been tolerated orare not expected to be tolerated,Have not provided adequate analgesia orare not expected to provide adequate analgesia.Tramadol hydrochloride and acetaminophen tablets should notbeused for an extended period of time.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Medsource Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
ANDA207152
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-22-2017
Listing Expiration
12-31-2026
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 45865-170-60 identifies a specific commercial package of 60 tablet, film coated in 1 bottle of Tramadol Hydrochloride And Acetaminophen, a human prescription drug labeled by Medsource Pharmaceuticals. This tablet, film coated is formulated for oral use and contains acetaminophen; tramadol 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 Medsource Pharmaceuticals on March 22, 2017. The current certification is valid through December 31, 2026.

How is this Medsource Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45865017060. 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)
45865-170-60
11-Digit CMS (5-4-2)
45865-0170-60

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