DrugDashboards

Ganirelix Acetate

Ganirelix Acetate · GANIRELIX ACETATE 250 ug/.5mL · Injection, Solution · Subcutaneous · Mullan Pharmaceutical Inc.

NDC 83301-0082-01 · 1 SYRINGE, GLASS in 1 CARTON / .5 mL in 1 SYRINGE, GLASS · ANDA · View full market →

The short version

7 companies supply this market — a reasonable cushion if one runs into trouble. 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$25.00$50.00$75.00Feb 2026Feb 2026$62.35
1 price point · per ML · last surveyed Invalid DateSource: CMS NADAC

Supply fragility

18Low risk

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

  • Class I/II recall on same molecule/form in past 12 months+8
  • 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
ANDA218855
TE code
AP
Approval date
Apr 23, 2025
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 83301-0082-01," retrieved September 3, 2026, https://drugdashboards.com/drug/83301008201.

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