Prescription drug · NDA
Macrilen (Macimorelin acetate) NDC 0169-1401
Macimorelin 60 mg/mg · Granule, For solution · Oral · Novo Nordisk
NDC codes
FDA NDC Directory| 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 NordiskNDC labeler code 0169
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205598
- Marketing start
- Marketing end
- 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
N400169140101followed by a unit qualifier and the quantityPackage 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 .
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.
About NDC 0169-1401
- What is NDC 0169-1401?
- 0169-1401 is the product NDC for Macrilen (macimorelin acetate), Macimorelin 60 mg/mg granule, for solution, listed with the FDA by Novo Nordisk. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Macrilen (Macimorelin acetate).
- What is the active ingredient?
- Macimorelin.
- Who is the labeler?
- Novo Nordisk, NDC labeler code 0169. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Macrilen?
- 1 other product NDC are listed under this name. See all Macrilen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Macrilen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Macrilenmacimorelin acetate | Macimorelin 60 mg/1817mg | Granule, For solutionOral | Aeterna Zentaris GmbH | 58844-130 | 58844-0130-01 |
Other NDCs under NDA 205598
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Macrilenmacimorelin acetate | Macimorelin 60 mg/1817mg | Granule, For solutionOral | Aeterna Zentaris GmbH | 58844-130 |