DrugDashboards

Gemcitabine

Gemcitabine · GEMCITABINE HYDROCHLORIDE 1 g/25mL · Injection, Powder, Lyophilized, For Solution · Intravenous · Fresenius Kabi USA, LLC

NDC 63323-0125-94 · 1 VIAL, SINGLE-DOSE in 1 BOX / 25 mL in 1 VIAL, SINGLE-DOSE · ANDA · View full market →

The short version

Just 3 companies supply this market — thin enough that a single exit would be felt immediately. Put together: this looks like a healthy supply — the boring kind, which is exactly what you want.

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$10.00$20.00$30.00Oct 2024Feb 2025$20.00
6 price points · per EA · last surveyed Invalid DateSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$41.88
Reported to Texas DSHS · 2026 annual filing · Fresenius Kabi USA

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

Medicaid spend (2025)

$536
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

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
ANDA090799
TE code
AP
Approval date
May 16, 2011
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 Gemcitabine (Injection, Powder, Lyophilized, For Solution)

LabelerStrengthFirst seenLast seen
Fresenius Kabi USA, LLCGEMCITABINE HYDROCHLORIDE 1 g/25mLJul 15, 2026Sep 3, 2026
Hospira, Inc.GEMCITABINE HYDROCHLORIDE 38 mg/mLJul 15, 2026Sep 3, 2026
Dr. Reddy's Laboratories LimitedGEMCITABINE HYDROCHLORIDE 1 g/25mLJul 15, 2026Sep 2, 2026
Dr. Reddy's Laboratories LimitedGEMCITABINE HYDROCHLORIDE 200 mg/5mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCGEMCITABINE HYDROCHLORIDE 2 g/50mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCGEMCITABINE HYDROCHLORIDE 200 mg/5mLJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Gemcitabine — NDC 63323-0125-94," retrieved September 3, 2026, https://drugdashboards.com/drug/63323012594.

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