DrugDashboards

Gemcitabine

Gemcitabine · GEMCITABINE HYDROCHLORIDE 38 mg/mL · Injection, Solution · Intravenous · Hikma Pharmaceuticals USA Inc.

NDC 00143-9340-01 · 1 VIAL in 1 CARTON / 5.26 mL in 1 VIAL · ANDA · View full market →

The short version

5 companies supply this market — a reasonable cushion if one runs into trouble. A Class II recall hit this product in the past year (McKesson).

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

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Estimated fill cost

WAC per package, as filed
$5.00
Reported to Texas DSHS · 2026 annual filing · Hikma Pharmaceuticals USA Inc.

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%

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
ANDA213175
TE code
AP
Approval date
Mar 7, 2023
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)

  • Class II · OngoingJun 10, 2026
    McKesson — Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.

Manufacturers of Gemcitabine (Injection, Solution)

LabelerStrengthFirst seenLast seen
Hikma Pharmaceuticals USA Inc.GEMCITABINE HYDROCHLORIDE 38 mg/mLJul 15, 2026Sep 3, 2026
Hospira, Inc.GEMCITABINE HYDROCHLORIDE 38 mg/mLJul 15, 2026Sep 3, 2026
Sagent PharmaceuticalsGEMCITABINE HYDROCHLORIDE 38 mg/mLJul 15, 2026Sep 2, 2026
Avyxa Pharma, LLCGEMCITABINE HYDROCHLORIDE 38 mg/mLJul 15, 2026Aug 31, 2026
BluePoint LaboratoriesGEMCITABINE HYDROCHLORIDE 100 mg/mLJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Gemcitabine — NDC 00143-9340-01," retrieved September 3, 2026, https://drugdashboards.com/drug/00143934001.

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