Calquence Tablet, Film Coated
NDC Package 0310-4513-60

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

Package Information

Calquence (acalabrutinib) tablets is a medication used to treat certain types of cancer (such as mantle cell lymphoma, small lymphocytic lymphoma - SLL, chronic lymphocytic leukemia - CLL). This formulation utilizes a tablet, film coated delivery system. Marketed by Astrazeneca Pharmaceuticals Lp, this product is identified by NDC 0310-4513 and is authorized under FDA application NDA216387.

Identification & Billing

NDC Package Code
0310-4513-60
Package Description
60 TABLET, FILM COATED in 1 BOTTLE
Product Code
0310-4513
11-Digit Billing Format
00310451360
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Calquence
Non-Proprietary Name
Acalabrutinib
Substance Name
Acalabrutinib
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)
ACALABRUTINIB 100 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat certain types of cancer (such as mantle cell lymphoma, small lymphocytic lymphoma - SLL, chronic lymphocytic leukemia - CLL). Acalabrutinib works by slowing or stopping the growth of cancer cells. It belongs to a class of drugs known as kinase inhibitors.

Regulatory & Marketing

Labeler Name
Astrazeneca Pharmaceuticals Lp
Product Type
Human Prescription Drug
FDA Application #
NDA216387
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-04-2022
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 0310-4513-60 identifies a specific commercial package of 60 tablet, film coated in 1 bottle of Calquence, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This tablet, film coated is formulated for oral use and contains acalabrutinib 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 Astrazeneca Pharmaceuticals Lp on August 04, 2022. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat certain types of cancer (such as mantle cell lymphoma, small lymphocytic lymphoma - SLL, chronic lymphocytic leukemia - CLL). Acalabrutinib works by slowing or stopping the growth of cancer cells. It belongs to a class of drugs known as kinase inhibitors.

How is this Astrazeneca Pharmaceuticals Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00310451360. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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 (4-4-2)
0310-4513-60
11-Digit CMS (5-4-2)
00310-4513-60

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