The short version
12 companies supply this market — deep enough that no single failure threatens the supply.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Fluorouracil
Fluorouracil · FLUOROURACIL 50 mg/mL · Injection, Solution · Intravenous · Alembic Pharmaceuticals Limited
NDC 46708-0751-50 · 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE · 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
- 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 · avg $67.21 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- ANDA217295
- TE code
- AP
- Approval date
- Mar 3, 2023
- 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 Fluorouracil (Injection, Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Accord Healthcare, Inc. | FLUOROURACIL 50 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Alembic Pharmaceuticals Inc. | FLUOROURACIL 50 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Alembic Pharmaceuticals Limited | FLUOROURACIL 50 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Avyxa Pharma, LLC | FLUOROURACIL 25 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| BluePoint Laboratories | FLUOROURACIL 50 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Eugia US LLC | FLUOROURACIL 50 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Fresenius Kabi USA, LLC | FLUOROURACIL 50 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Gland Pharma Limited | FLUOROURACIL 50 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Meitheal Pharmaceuticals Inc. | FLUOROURACIL 50 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Xiromed LLC | FLUOROURACIL 50 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| ProPharma Distribution | FLUOROURACIL 50 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Sagent Pharmaceuticals | FLUOROURACIL 50 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Fluorouracil — NDC 46708-0751-50," retrieved September 3, 2026, https://drugdashboards.com/drug/46708075150.
Free to cite with attribution — see how the data is put together.