DrugDashboards

Lanreotide Acetate

Lanreotide Acetate · LANREOTIDE ACETATE 90 mg/.3mL · Injection · Subcutaneous · Exelan Pharmaceuticals, Inc.

NDC 76282-0719-67 · 1 POUCH in 1 CARTON / 1 SYRINGE in 1 POUCH / .3 mL in 1 SYRINGE · ANDA · View full market →

The short version

4 companies supply this market — a reasonable cushion if one runs into trouble. One of its named manufacturing plants, Pharmathen International S.A., failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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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.

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 $8,481.92 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA217193
TE code
AB
Approval date
May 21, 2024
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 Lanreotide Acetate (Injection)

LabelerStrengthFirst seenLast seen
Cipla USA Inc.LANREOTIDE ACETATE 120 mg/.5mLJul 15, 2026Sep 3, 2026
Cipla USA Inc.LANREOTIDE ACETATE 90 mg/.3mLJul 15, 2026Sep 3, 2026
Cipla USA Inc.LANREOTIDE ACETATE 60 mg/.2mLJul 15, 2026Sep 3, 2026
Exelan Pharmaceuticals, Inc.LANREOTIDE ACETATE 120 mg/.5mLJul 15, 2026Sep 2, 2026
Exelan Pharmaceuticals, Inc.LANREOTIDE ACETATE 90 mg/.3mLJul 15, 2026Sep 2, 2026
Exelan Pharmaceuticals, Inc.LANREOTIDE ACETATE 60 mg/.2mLJul 15, 2026Sep 2, 2026
Ipsen Biopharmaceuticals, Inc.LANREOTIDE ACETATE 60 mg/.2mLJul 15, 2026Sep 2, 2026
Ipsen Biopharmaceuticals, Inc.LANREOTIDE ACETATE 120 mg/.5mLJul 15, 2026Sep 2, 2026
Ipsen Biopharmaceuticals, Inc.LANREOTIDE ACETATE 90 mg/.3mLJul 15, 2026Sep 2, 2026
Synergy Health AST, LLCLANREOTIDE ACETATE 120 mg/.5mLJul 15, 2026Sep 2, 2026
Synergy Health AST, LLCLANREOTIDE ACETATE 90 mg/.3mLJul 15, 2026Sep 2, 2026
Synergy Health AST, LLCLANREOTIDE ACETATE 60 mg/.2mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Lanreotide Acetate — NDC 76282-0719-67," retrieved September 3, 2026, https://drugdashboards.com/drug/76282071967.

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