DrugDashboards

Ganirelix Acetate

Ganirelix Acetate · GANIRELIX ACETATE 250 ug/.5mL · Injection · Subcutaneous · Amphastar Pharmaceuticals, Inc.

NDC 00548-5001-00 · 1 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE · 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.

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.

  • Pharmacies pay (NADAC)$62.35per MLinvoice-surveyed acquisition cost · Dec 17, 2025
  • Federal contracts pay (FSS)$81.85per package of 0.5MLAmphastar Pharmaceuticals, Inc. · Sep 14, 2022

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 Dec 17, 2025Source: CMS NADAC

Medicaid spend (2023)

$2,350
13 prescriptions paid by Medicaid nationally · all Medicaid spend →

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
ANDA212613
TE code
AP
Approval date
Apr 7, 2022
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 00548-5001-00," retrieved September 3, 2026, https://drugdashboards.com/drug/00548500100.

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