The short version
19 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.
Phytonadione
phytonadione · PHYTONADIONE 10 mg/mL · Injection, Emulsion · Intramuscular; Intravenous; Subcutaneous · Henry Schein, Inc.
NDC 00404-9969-01 · 1 AMPULE in 1 BAG / 1 mL in 1 AMPULE · 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.
Medicare Part B (ASP)
Payment limit per 1 MG
$3.253
HCPCS J3430 · 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
- ANDA207719
- TE code
- AB1
- Approval date
- May 22, 2019
- 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 phytonadione (Injection, Emulsion)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Cipla USA Inc. | PHYTONADIONE 1 mg/.5mL | Jul 15, 2026 | Sep 3, 2026 |
| Alembic Pharmaceuticals Inc. | PHYTONADIONE 1 mg/.5mL | Jul 15, 2026 | Sep 2, 2026 |
| Alembic Pharmaceuticals Limited | PHYTONADIONE 1 mg/.5mL | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals LLC | PHYTONADIONE 1 mg/.5mL | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals Private Limited | PHYTONADIONE 10 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Baxter Healthcare Corporation | PHYTONADIONE 1 mg/.5mL | Jul 15, 2026 | Sep 2, 2026 |
| Caplin Steriles Limited | PHYTONADIONE 10 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Cipla USA Inc. | PHYTONADIONE 10 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Dr.Reddy's Laboratories Inc | PHYTONADIONE 10 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Fresenius Kabi USA, LLC | PHYTONADIONE 10 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Gland Pharma Limited | PHYTONADIONE 10 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Glenmark Pharmaceuticals Inc | PHYTONADIONE 10 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Henry Schein, Inc. | PHYTONADIONE 1 mg/.5mL | Jul 15, 2026 | Sep 2, 2026 |
| Henry Schein, Inc. | PHYTONADIONE 10 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| HF Acquisition Co LLC, DBA HealthFirst | PHYTONADIONE 10 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Hospira, Inc. | PHYTONADIONE 2 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Hospira, Inc. | PHYTONADIONE 10 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| International Medication Systems, Limited | PHYTONADIONE 1 mg/.5mL | Jul 15, 2026 | Sep 2, 2026 |
| Orbicular Pharmaceutical Technologies Private Limited | PHYTONADIONE 1 mg/.5mL | Jul 15, 2026 | Sep 2, 2026 |
| Sagent Pharmaceuticals | PHYTONADIONE 1 mg/.5mL | Jul 15, 2026 | Sep 2, 2026 |
| Sun Pharmaceutical Industries, Inc. | PHYTONADIONE 1 mg/.5mL | Jul 15, 2026 | Sep 2, 2026 |
| Xiromed LLC | PHYTONADIONE 10 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, "Phytonadione — NDC 00404-9969-01," retrieved September 3, 2026, https://drugdashboards.com/drug/00404996901.
Free to cite with attribution — see how the data is put together.