Ticagrelor Tablet
NDC Package 53401-028-42

11-digit billing NDC: 53401002842 · Billing unit: EA · 1800 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Ticagrelor tablets are indicated to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. This formulation utilizes a tablet delivery system. Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 53401-028 and is authorized under FDA application ANDA208596.

Identification & Billing

NDC Package Code
53401-028-42
Package Description
1800 TABLET in 1 BOTTLE
Product Code
53401-028
11-Digit Billing Format
53401002842
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1800 EA
RxNorm Crosswalk
RxCUI: 1116635 - ticagrelor 90 MG Oral Tablet

Clinical Specifications

Proprietary Name
Ticagrelor
Non-Proprietary Name
Ticagrelor
Substance Name
Ticagrelor
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TICAGRELOR 90 mg/1
Pharmacologic Class
Usage Information
Ticagrelor tablets are indicated to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. Ticagrelor tablets also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS [see Clinical Studies (14.1)] .

Regulatory & Marketing

Labeler Name
Aphena Pharma Solutions - Tennessee, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA208596
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-24-2025
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 53401-028-42 identifies a specific commercial package of 1800 tablet in 1 bottle of Ticagrelor, a human prescription drug labeled by Aphena Pharma Solutions - Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1800 billable units per package. This tablet is formulated for oral use and contains ticagrelor 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 Aphena Pharma Solutions - Tennessee, Llc on April 24, 2025. The current certification is valid through December 31, 2027.

How is this Aphena Pharma Solutions - Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53401002842. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1800 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)
53401-028-42
11-Digit CMS (5-4-2)
53401-0028-42

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