Macrilen Granule, For Solution
NDC Package 58844-130-01

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

Package Information

Macrilen (macimorelin acetate) granules is mACRILEN is indicated for the diagnosis of adult growth hormone deficiency (AGHD). This formulation utilizes a granule, for solution delivery system. Marketed by Aeterna Zentaris Gmbh, this product is identified by NDC 58844-130 and is authorized under FDA application NDA205598.

Identification & Billing

NDC Package Code
58844-130-01
Package Description
1 POUCH in 1 CARTON / 60 mg in 1 POUCH
Product Code
58844-130
11-Digit Billing Format
58844013001

Clinical Specifications

Proprietary Name
Macrilen
Non-Proprietary Name
Macimorelin Acetate
Substance Name
Macimorelin
Dosage Form
Granule, For Solution - A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MACIMORELIN 60 mg/1817mg
Pharmacologic Class
Usage Information
MACRILEN is indicated for the diagnosis of adult growth hormone deficiency (AGHD).

Regulatory & Marketing

Labeler Name
Aeterna Zentaris Gmbh
Product Type
Human Prescription Drug
FDA Application #
NDA205598
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-29-2018
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 58844-130-01 identifies a specific commercial package of 1 pouch in 1 carton / 60 mg in 1 pouch of Macrilen, a human prescription drug labeled by Aeterna Zentaris Gmbh. This granule, for solution is formulated for oral use and contains macimorelin 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 Aeterna Zentaris Gmbh on January 29, 2018. The current certification is valid through December 31, 2027.

How is this Aeterna Zentaris Gmbh product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58844013001. 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)
58844-130-01
11-Digit CMS (5-4-2)
58844-0130-01

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