DrugDashboards

Ganirelix Acetate

Ganirelix Acetate · GANIRELIX ACETATE 250 ug/.5mL · Injection · Subcutaneous · Fresenius Kabi USA, LLC

NDC 65219-0028-05 · 1 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS · ANDA · View full market →

The short version

Just 3 companies supply this market — thin enough that a single exit would be felt immediately. The price has fallen 34% in a year, to $62.35 per mL — and generics that get this cheap tend to get abandoned rather than defended. Put together: this looks like a healthy supply — the boring kind, which is exactly what you want. 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

$0$50.00$100.00$150.00Aug 2024Dec 2025$62.35
17 price points · per ML · last surveyed Invalid DateSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$30.00
Reported to Texas DSHS · 2026 annual filing · Fresenius Kabi USA

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

Supply fragility

20Low risk

Some pressure is visible, but not much — here’s everything the score found to count.

  • 3 active manufacturers+10
  • sterile injectable+10

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

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 →

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 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
ANDA215658
TE code
AP
Approval date
Feb 28, 2023
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)

LabelerStrengthFirst seenLast seen
Amphastar Pharmaceuticals, Inc.GANIRELIX ACETATE 250 ug/.5mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCGANIRELIX ACETATE 250 ug/.5mLJul 15, 2026Sep 2, 2026
Xiromed LLCGANIRELIX 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 65219-0028-05," retrieved September 3, 2026, https://drugdashboards.com/drug/65219002805.

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