The short version
7 companies supply this market — a reasonable cushion if one runs into trouble.
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Docetaxel
Docetaxel · DOCETAXEL ANHYDROUS 10 mg/mL · Injection · Intravenous · Gland Pharma Limited
NDC 68083-0399-01 · 1 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL 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.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- Gland Pharma LimitedIndiaanalysis · 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 · avg $480.15 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- ANDA213510
- TE code
- AP
- Approval date
- Jul 1, 2021
- 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 Docetaxel (Injection)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Gland Pharma Limited | DOCETAXEL ANHYDROUS 10 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Alembic Pharmaceuticals Inc. | DOCETAXEL ANHYDROUS 10 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Alembic Pharmaceuticals Limited | DOCETAXEL ANHYDROUS 10 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals LLC | DOCETAXEL ANHYDROUS 160 mg/8mL | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals LLC | DOCETAXEL ANHYDROUS 80 mg/4mL | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals LLC | DOCETAXEL ANHYDROUS 20 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | DOCETAXEL 20 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | DOCETAXEL 80 mg/4mL | Jul 15, 2026 | Sep 2, 2026 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | DOCETAXEL 160 mg/8mL | Jul 15, 2026 | Sep 2, 2026 |
| Wuhan Calmland Pharmaceuticals Co., Ltd. | DOCETAXEL 100 mg/100mg | Jul 15, 2026 | Sep 2, 2026 |
| Baxter Healthcare Corporation | DOCETAXEL ANHYDROUS 10 mg/mL | Jul 15, 2026 | Aug 28, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Docetaxel — NDC 68083-0399-01," retrieved September 3, 2026, https://drugdashboards.com/drug/68083039901.
Free to cite with attribution — see how the data is put together.