Camcevi Injection, Emulsion
NDC Package 69448-014-63

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

Package Information

Camcevi (leuprolide) injection is cAMCEVI is indicated for the treatment of adult patients with advanced prostate cancer. This formulation utilizes a injection, emulsion delivery system. Marketed by Accord Biopharma, Inc., this product is identified by NDC 69448-014 and is authorized under FDA application NDA211488.

Identification & Billing

NDC Package Code
69448-014-63
Package Description
1 SYRINGE in 1 CARTON / .37 g in 1 SYRINGE
Product Code
69448-014
11-Digit Billing Format
69448001463
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Camcevi
Non-Proprietary Name
Leuprolide
Substance Name
Leuprolide Mesylate
Dosage Form
Injection, Emulsion - An emulsion consisting of a sterile, pyrogen-free preparation intended to be administered parenterally.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
LEUPROLIDE MESYLATE 42 mg/.37g
Pharmacologic Class
Usage Information
CAMCEVI is indicated for the treatment of adult patients with advanced prostate cancer.

Regulatory & Marketing

Labeler Name
Accord Biopharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA211488
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-05-2022
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 69448-014-63 identifies a specific commercial package of 1 syringe in 1 carton / .37 g in 1 syringe of Camcevi, a human prescription drug labeled by Accord Biopharma, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, emulsion is formulated for subcutaneous use and contains leuprolide mesylate 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 Accord Biopharma, Inc. on April 05, 2022. The current certification is valid through December 31, 2027.

How is this Accord Biopharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69448001463. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
69448-014-63
11-Digit CMS (5-4-2)
69448-0014-63

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