DrugDashboards

Ganirelix Acetate

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

NDC 70748-0274-01 · 1 TRAY in 1 CARTON / 1 SYRINGE, GLASS in 1 TRAY / 1 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. 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. A Class II recall hit this product in the past year (Lupin Pharmaceuticals Inc.). Put together: worth watching — several of the pressures that precede supply trouble are present at once. 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

Supply fragility

25Elevated risk

The score is counting real pressure here. One of these alone is routine; it’s the combination that makes this market worth watching.

  • Class I/II recall in past 12 months+15
  • 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
ANDA216075
TE code
AP
Approval date
Nov 16, 2023
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · OngoingNov 13, 2025
    Lupin Pharmaceuticals Inc.Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.

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 70748-0274-01," retrieved September 3, 2026, https://drugdashboards.com/drug/70748027401.

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