Macrilen Granule, For Solution
NDC Package 0169-1401-01

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 Novo Nordisk, this product is identified by NDC 0169-1401 and is authorized under FDA application NDA205598.

Identification & Billing

NDC Package Code
0169-1401-01
Package Description
1 POUCH in 1 CARTON / 60 mg in 1 POUCH
Product Code
0169-1401
11-Digit Billing Format
00169140101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

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/mg
Pharmacologic Class
Usage Information
MACRILEN is indicated for the diagnosis of adult growth hormone deficiency (AGHD).

Regulatory & Marketing

Labeler Name
Novo Nordisk
Product Type
Human Prescription Drug
FDA Application #
NDA205598
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-31-2022
End Marketing Date
02-28-2027
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 0169-1401-01 identifies a specific commercial package of 1 pouch in 1 carton / 60 mg in 1 pouch of Macrilen, a human prescription drug labeled by Novo Nordisk. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. 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 Novo Nordisk on January 31, 2022.

How is this Novo Nordisk product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00169140101. 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 (4-4-2)
0169-1401-01
11-Digit CMS (5-4-2)
00169-1401-01

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