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 Hydrochloride · GEMCITABINE HYDROCHLORIDE 200 mg/1 · Injection, Powder, Lyophilized, For Solution · Intravenous · NorthStar Rx LLC
NDC 16714-0909-01 · 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 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
$10.50
Reported to Texas DSHS · 2026 annual filing · Northstar Rx Llc
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicare Part B (ASP)
Payment limit per 200 MG
$2.884
HCPCS J9201 · Jul 1, 2026 quarter · typically ASP + 6%
Medicaid spend (2025)
$3,018
157 prescriptions paid by Medicaid nationally · all Medicaid spend →
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
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
- ANDA091365
- 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 — NDC 16714-0909-01," retrieved September 3, 2026, https://drugdashboards.com/drug/16714090901.
Free to cite with attribution — see how the data is put together.