The short version
5 companies supply this market — a reasonable cushion if one runs into trouble.
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 100 mg/mL · Injection, Solution · Intravenous · BluePoint Laboratories
NDC 68001-0348-36 · 1 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE · NDA · 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
$55.44
Reported to Texas DSHS · 2025 annual filing · Blue Point Laboratories
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicaid spend (2025)
$1,020
42 prescriptions paid by Medicaid nationally · all Medicaid spend →
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- analysis · manufacture
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
- NDA209604
- TE code
- —
- Approval date
- Aug 3, 2017
- Patents / exclusivity
- None on file
Shortage history
- Planned discontinuation — Gemcitabine Hydrochloride, Injection, 1 g/26.3 mL (38 mg/mL), sterile solution in a single-dose glass vial NovaPlus (NDC 0409-0181-25)Sep 11, 2025
- Planned discontinuation — Gemcitabine Hydrochloride, Injection, 2 g/52.6 mL (38 mg/mL), sterile solution in a single-dose glass vial NovaPlus (NDC 0409-0182-25)Sep 11, 2025
- Planned discontinuation — Gemcitabine Hydrochloride, Injection, 200 mg/5.26 mL (38 mg/mL), sterile solution in a single-dose glass vial NovaPlus (NDC 0409-0183-25)Sep 11, 2025
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Gemcitabine (Injection, Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Hikma Pharmaceuticals USA Inc. | GEMCITABINE HYDROCHLORIDE 38 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Hospira, Inc. | GEMCITABINE HYDROCHLORIDE 38 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Sagent Pharmaceuticals | GEMCITABINE HYDROCHLORIDE 38 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Avyxa Pharma, LLC | GEMCITABINE HYDROCHLORIDE 38 mg/mL | Jul 15, 2026 | Aug 31, 2026 |
| BluePoint Laboratories | GEMCITABINE HYDROCHLORIDE 100 mg/mL | 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 68001-0348-36," retrieved September 3, 2026, https://drugdashboards.com/drug/68001034836.
Free to cite with attribution — see how the data is put together.