DrugDashboards

Increlex

Mecasermin · MECASERMIN 40 mg/4mL · Injection · Subcutaneous · Eton Pharmaceuticals, Inc.

NDC 71863-0216-04 · 1 VIAL, MULTI-DOSE in 1 CARTON / 4 mL in 1 VIAL, MULTI-DOSE · BLA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. One of its named manufacturing plants, Simtra Deutschland GmbH, failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

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
$16,161.00
Reported to Texas DSHS · 2026 annual filing · Eton Pharmaceuticals, Inc.

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Is this a "specialty" drug?

There's no legal definition — it meets 2 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
BLA021839
TE code
Approval date
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Mecasermin (Injection)

LabelerStrengthFirst seenLast seen
Eton Pharmaceuticals, Inc.MECASERMIN 40 mg/4mLJul 15, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Increlex — NDC 71863-0216-04," retrieved September 3, 2026, https://drugdashboards.com/drug/71863021604.

Free to cite with attribution — see how the data is put together.