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 hydrochloride
Gemcitabine hydrochloride · GEMCITABINE HYDROCHLORIDE 200 mg/5mL · Injection, Powder, Lyophilized, For Solution · Intravenous · Teyro Labs Private Limited
NDC 82511-0008-20 · 1 VIAL, SINGLE-USE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-USE · 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.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- analysis · manufacture · pack
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
- ANDA078759
- TE code
- AP
- Approval date
- Jul 25, 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 hydrochloride (Injection, Powder, Lyophilized, For Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Gland Pharma Limited | GEMCITABINE HYDROCHLORIDE 1 g/25mL | Jul 15, 2026 | Sep 2, 2026 |
| Gland Pharma Limited | GEMCITABINE HYDROCHLORIDE 200 mg/5mL | Jul 15, 2026 | Sep 2, 2026 |
| Meitheal Pharmaceuticals Inc. | GEMCITABINE HYDROCHLORIDE 1 g/1 | Jul 15, 2026 | Sep 2, 2026 |
| Meitheal Pharmaceuticals Inc. | GEMCITABINE HYDROCHLORIDE 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| NorthStar Rx LLC | GEMCITABINE HYDROCHLORIDE 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| NorthStar Rx LLC | GEMCITABINE HYDROCHLORIDE 1 g/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sagent Pharmaceuticals | GEMCITABINE HYDROCHLORIDE 200 mg/5mL | Jul 15, 2026 | Sep 2, 2026 |
| Sagent Pharmaceuticals | GEMCITABINE HYDROCHLORIDE 1 g/25mL | Jul 15, 2026 | Sep 2, 2026 |
| Teyro Labs Private Limited | GEMCITABINE HYDROCHLORIDE 1 g/25mL | Jul 15, 2026 | Sep 2, 2026 |
| Teyro Labs Private Limited | GEMCITABINE HYDROCHLORIDE 200 mg/5mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Gemcitabine hydrochloride — NDC 82511-0008-20," retrieved September 3, 2026, https://drugdashboards.com/drug/82511000820.
Free to cite with attribution — see how the data is put together.