Etcamah Tablet, Film Coated
NDC Package 0310-0075-01

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

Package Information

Etcamah (camizestrant) tablets is eTCAMAH in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test [see Dosage and Administration (2.1)].This indication is approved under accelerated approval based on progression-free survival as measured from detection of ESR1 mutation [see Clinical Studies (14)]. This formulation utilizes a tablet, film coated delivery system. Marketed by Astrazeneca Pharmaceuticals Lp, this product is identified by NDC 0310-0075 and is authorized under FDA application NDA220359.

Identification & Billing

NDC Package Code
0310-0075-01
Package Description
28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
0310-0075
11-Digit Billing Format
00310007501

Clinical Specifications

Proprietary Name
Etcamah
Non-Proprietary Name
Camizestrant
Substance Name
Camizestrant
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)
CAMIZESTRANT 75 mg/1
Usage Information
ETCAMAH in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test [see Dosage and Administration (2.1)].This indication is approved under accelerated approval based on progression-free survival as measured from detection of ESR1 mutation [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Regulatory & Marketing

Labeler Name
Astrazeneca Pharmaceuticals Lp
Product Type
Human Prescription Drug
FDA Application #
NDA220359
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-04-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0310-0075). Click a package code to view its specific billing and regulatory data.

0310-0075-95
7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

* 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 0310-0075-01 identifies a specific commercial package of 28 tablet, film coated in 1 bottle, plastic of Etcamah, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. This tablet, film coated is formulated for oral use and contains camizestrant 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 September 04, 2026. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00310007501. 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)
0310-0075-01
11-Digit CMS (5-4-2)
00310-0075-01

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