Tapentadol Hydrochloride Tablet, Film Coated
NDC Package 42806-628-01

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

Package Information

Tapentadol Hydrochloride tablets is tapentadol tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults.Limitations of UseBecause of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dose or duration [see Warnings and Precautions (5.1)], and persist over the course of therapy, reserve opioid analgesics, including tapentadol tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.Pediatric use information is approved for Collegium Pharmaceutical, Inc.’s NUCYNTA tablets. This formulation utilizes a tablet, film coated delivery system. Marketed by Epic Pharma Llc, this product is identified by NDC 42806-628 and is authorized under FDA application ANDA214378.

Identification & Billing

NDC Package Code
42806-628-01
Package Description
100 TABLET, FILM COATED in 1 BOTTLE
Product Code
42806-628
11-Digit Billing Format
42806062801
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tapentadol Hydrochloride
Non-Proprietary Name
Tapentadol Hydrochloride
Substance Name
Tapentadol 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)
TAPENTADOL HYDROCHLORIDE 100 mg/1
Pharmacologic Class
Usage Information
Tapentadol tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults.Limitations of UseBecause of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dose or duration [see Warnings and Precautions (5.1)], and persist over the course of therapy, reserve opioid analgesics, including tapentadol tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.Pediatric use information is approved for Collegium Pharmaceutical, Inc.’s NUCYNTA tablets. However, due to Collegium Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Epic Pharma Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA214378
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-31-2021
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 42806-628-01 identifies a specific commercial package of 100 tablet, film coated in 1 bottle of Tapentadol Hydrochloride, a human prescription drug labeled by Epic Pharma Llc. This tablet, film coated is formulated for oral use and contains tapentadol 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 Epic Pharma Llc on December 31, 2021. The current certification is valid through December 31, 2027.

How is this Epic Pharma Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42806062801. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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)
42806-628-01
11-Digit CMS (5-4-2)
42806-0628-01

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