DrugDashboards

BYNFEZIA Pen

octreotide acetate · OCTREOTIDE ACETATE 2.5 mg/mL · Injection · Subcutaneous · Sun Pharmaceutical Industries, Inc.

NDC 62756-0452-37 · 2 CARTRIDGE in 1 CARTON / 2.8 mL in 1 CARTRIDGE · NDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. Historically, drugs in this position went on to a new shortage within 90 days about 0.5% of the time — roughly 4× the typical drug (0.1%).

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.

Supply fragility

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

90-day shortage risk (model v2)

0.5%chance of a new FDA shortage posting for octreotide acetate (injectable) in the next 90 days

sterile injectable · OAI inspection at a producing facility (24 months) · sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is 4× that.

Backtested statistical model over the whole market, not this package alone. Model details →

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 · avg $970.90 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA213224
TE code
Approval date
Sep 27, 2024
Patents / exclusivity
5 patents, 0 exclusivities
TypeNumber / codeExpires
patent12350475Dec 29, 2041
patent11246991Nov 3, 2040
patent11534553Nov 3, 2040
patent11052196Nov 3, 2040
patent10342850May 15, 2038

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of octreotide acetate (Injection)

LabelerStrengthFirst seenLast seen
Sun Pharmaceutical Industries, Inc.OCTREOTIDE ACETATE 2.5 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "BYNFEZIA Pen — NDC 62756-0452-37," retrieved September 3, 2026, https://drugdashboards.com/drug/62756045237.

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