The short version
Just 3 companies supply this market — thin enough that a single exit would be felt immediately.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Gemcitabine
Gemcitabine · GEMCITABINE HYDROCHLORIDE 2 g/50mL · Injection, Powder, Lyophilized, For Solution · Intravenous · Fresenius Kabi USA, LLC
NDC 63323-0126-03 · 1 VIAL, SINGLE-DOSE in 1 BOX / 50 mL in 1 VIAL, SINGLE-DOSE · ANDA · View full market →
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
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Estimated fill cost
WAC per package, as filed
$128.70
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)
$2,976
12 prescriptions paid by Medicaid nationally · all Medicaid spend →
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- Fresenius Kabi USA, LLCUnited Statesmanufacture
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)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Fresenius Kabi USA, LLC | GEMCITABINE HYDROCHLORIDE 1 g/25mL | Jul 15, 2026 | Sep 3, 2026 |
| Hospira, Inc. | GEMCITABINE HYDROCHLORIDE 38 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Dr. Reddy's Laboratories Limited | GEMCITABINE HYDROCHLORIDE 1 g/25mL | Jul 15, 2026 | Sep 2, 2026 |
| Dr. Reddy's Laboratories Limited | GEMCITABINE HYDROCHLORIDE 200 mg/5mL | Jul 15, 2026 | Sep 2, 2026 |
| Fresenius Kabi USA, LLC | GEMCITABINE HYDROCHLORIDE 2 g/50mL | Jul 15, 2026 | Sep 2, 2026 |
| Fresenius Kabi USA, LLC | GEMCITABINE HYDROCHLORIDE 200 mg/5mL | Jul 15, 2026 | Aug 31, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Gemcitabine — NDC 63323-0126-03," retrieved September 3, 2026, https://drugdashboards.com/drug/63323012603.
Free to cite with attribution — see how the data is put together.