The short version
Just 2 companies supply this market — thin enough that a single exit would be felt immediately.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Macrilen
Macimorelin acetate · MACIMORELIN 60 mg/mg · Granule, For Solution · Oral · Novo Nordisk
NDC 00169-1401-01 · 1 POUCH in 1 CARTON / 60 mg in 1 POUCH · NDA · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Estimated fill cost
WAC per package, as filed
$4,500.00
Reported to Texas DSHS · 2023 annual filing · Novo Nordisk Inc.
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Regulatory
- Application
- NDA205598
- TE code
- —
- Approval date
- Dec 20, 2017
- Patents / exclusivity
- 2 patents, 0 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| patent | 8192719*PED | Apr 12, 2028 |
| patent | 8192719 | Oct 12, 2027 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Macimorelin acetate (Granule, For Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Aeterna Zentaris GmbH | MACIMORELIN 60 mg/1817mg | Jul 15, 2026 | Sep 2, 2026 |
| Novo Nordisk | MACIMORELIN 60 mg/mg | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Macrilen — NDC 00169-1401-01," retrieved September 3, 2026, https://drugdashboards.com/drug/00169140101.
Free to cite with attribution — see how the data is put together.