Macrilen (macimorelin acetate) NDC 0169-1401

NDC codes

FDA NDC Directory

Product NDC (as listed)0169-1401Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00169-1401Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0169-1401-01	00169140101	1 POUCH in 1 CARTON (0169-1401-01) / 60 mg in 1 POUCHMarketed from Jan 31, 2022

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Macrilen
Generic name (nonproprietary): macimorelin acetate
Active ingredients: Macimorelin — 60 mg/mg
Dosage form: Granule, For solution
Route: Oral
Labeler: Novo Nordisk
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 205598
Marketing start: Jan 31, 2022
Marketing end: Feb 28, 2027
Other FDA classes: Growth Hormone Secretagogue Receptor Agonists (Mechanism)
Identifiers: Product ID 0169-1401_ed003972-d498-43fc-b809-05a47d86b8daSPL ID ed003972-d498-43fc-b809-05a47d86b8daSPL set ID 6034c9b8-5a36-4961-a5dd-11ebf7bdab78UNII 8680B21W73
Pharmacologic class: Growth Hormone Secretagogue Receptor Agonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400169140101 followed by a unit qualifier and the quantity

Package 00169-1401-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jan 30, 2021.

Indications (excerpt from the label)

MACRILEN is indicated for the diagnosis of adult growth hormone deficiency (AGHD). MACRILEN is a growth hormone (GH) secretagogue receptor agonist indicated for the diagnosis of adult growth hormone deficiency ( 1 ). Limitations of Use : The safety and diagnostic performance has not been established for subjects with BMI > 40kg/m 2 ( 1 ). Limitations of Use The safety and diagnostic performance of MACRILEN have not been established for subjects with a body mass index (BMI) > 40 kg/m 2 .

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 205598

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 205598
Product	Strength	Form · route	Labeler	Product NDC
Macrilenmacimorelin acetate	Macimorelin 60 mg/1817mg	Granule, For solutionOral	Aeterna Zentaris GmbH	58844-130