DrugDashboards

Lanreotide Acetate

Lanreotide Acetate · LANREOTIDE ACETATE 120 mg/.5mL · Injection · Subcutaneous · Cipla USA Inc.

NDC 69097-0906-67 · 1 POUCH in 1 CARTON / 1 SYRINGE in 1 POUCH / .5 mL in 1 SYRINGE · ANDA · View full market →

The short version

4 companies supply this market — a reasonable cushion if one runs into trouble. A Class II recall hit this product in the past year (Cipla USA, Inc.). One of its named manufacturing plants, Pharmathen International S.A., 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.

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

  • Medicare Part B pays (ASP+6%)$37.43per billing unit (1 MG)HCPCS J1930 · Jul 1, 2026
  • Part D plans paid (avg)$16,248.29per dosage unitgross, before rebates — matched by drug name · 2024

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
$6,693.40
Reported to Texas DSHS · 2025 annual filing · Cipla USA Inc.

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

Medicare Part B (ASP)

Payment limit per 1 MG
$37.428
HCPCS J1930 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2025)

$676,335
243 prescriptions paid by Medicaid nationally · all Medicaid spend →

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)

  • Class II · OngoingMar 13, 2026
    Cipla USA, Inc.Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.

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 69097-0906-67," retrieved September 3, 2026, https://drugdashboards.com/drug/69097090667.

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