DrugDashboards

Ganirelix Acetate

Ganirelix Acetate · GANIRELIX ACETATE 250 ug/.5mL · Injection, Solution · Subcutaneous · Organon LLC

NDC 78206-0138-01 · 1 BLISTER PACK in 1 CARTON / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS · NDA · View full market →

The short version

7 companies supply this market — a reasonable cushion if one runs into trouble. Historically, drugs in this position went on to a new shortage within 90 days about 0.4% of the time — roughly 3× 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.

Estimated fill cost

WAC per package, as filed
$216.49
Reported to Texas DSHS · 2026 annual filing · Organon LLC

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

Supply fragility

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

90-day shortage risk (model v2)

0.4%chance of a new FDA shortage posting for ganirelix acetate (injectable) in the next 90 days

sterile injectable · sole-source market · 1 Class I/II recall(s) in 12 months

For scale: the typical drug’s chance is about 0.1% — this one is 3× that.

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

Is this a "specialty" drug?

There's no legal definition — it meets 1 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
NDA021057
TE code
AP
Approval date
Jul 29, 1999
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 Ganirelix Acetate (Injection, Solution)

LabelerStrengthFirst seenLast seen
Ferring Pharmaceuticals Inc.GANIRELIX ACETATE 250 ug/.5mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedGANIRELIX ACETATE 250 ug/.5mLJul 15, 2026Sep 2, 2026
Lupin Pharmaceuticals, Inc.GANIRELIX ACETATE 250 ug/.5mLJul 15, 2026Sep 2, 2026
Meitheal Pharmaceuticals Inc.GANIRELIX ACETATE 250 ug/.5mLJul 15, 2026Sep 2, 2026
Mullan Pharmaceutical Inc.GANIRELIX ACETATE 250 ug/.5mLJul 15, 2026Sep 2, 2026
Organon LLCGANIRELIX ACETATE 250 ug/.5mLJul 15, 2026Sep 2, 2026
Qilu Pharmaceutical Co., Ltd.GANIRELIX ACETATE 250 ug/.5mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Ganirelix Acetate — NDC 78206-0138-01," retrieved September 3, 2026, https://drugdashboards.com/drug/78206013801.

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