DrugDashboards

Phytonadione

Phytonadione · PHYTONADIONE 10 mg/mL · Injection, Emulsion · Intramuscular; Intravenous; Subcutaneous · Cipla USA Inc.

NDC 69097-0708-96 · 10 VIAL in 1 CARTON / 1 mL in 1 VIAL · ANDA · View full market →

The short version

19 companies supply this market — deep enough that no single failure threatens the supply. A Class II recall hit this product in the past year (Cipla Limited). One of its named manufacturing plants, Immacule Lifesciences Private Limited, failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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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
$427.70
Reported to Texas DSHS · 2025 annual filing · Cipla USA Inc.

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Medicare Part B (ASP)

Payment limit per 1 MG
$3.253
HCPCS J3430 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2025)

$1,354
41 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

Where it's made

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
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA214596
TE code
AB2
Approval date
Apr 22, 2022
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · OngoingOct 31, 2025
    Cipla Limited — Failed Stability Specifications: Observed OOS results: eg results for colour index

Manufacturers of Phytonadione (Injection, Emulsion)

LabelerStrengthFirst seenLast seen
Cipla USA Inc.PHYTONADIONE 1 mg/.5mLJul 15, 2026Sep 3, 2026
Alembic Pharmaceuticals Inc.PHYTONADIONE 1 mg/.5mLJul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals LimitedPHYTONADIONE 1 mg/.5mLJul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCPHYTONADIONE 1 mg/.5mLJul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals Private LimitedPHYTONADIONE 10 mg/mLJul 15, 2026Sep 2, 2026
Baxter Healthcare CorporationPHYTONADIONE 1 mg/.5mLJul 15, 2026Sep 2, 2026
Caplin Steriles LimitedPHYTONADIONE 10 mg/mLJul 15, 2026Sep 2, 2026
Cipla USA Inc.PHYTONADIONE 10 mg/mLJul 15, 2026Sep 2, 2026
Dr.Reddy's Laboratories IncPHYTONADIONE 10 mg/mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCPHYTONADIONE 10 mg/mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedPHYTONADIONE 10 mg/mLJul 15, 2026Sep 2, 2026
Glenmark Pharmaceuticals IncPHYTONADIONE 10 mg/mLJul 15, 2026Sep 2, 2026
Henry Schein, Inc.PHYTONADIONE 1 mg/.5mLJul 15, 2026Sep 2, 2026
Henry Schein, Inc.PHYTONADIONE 10 mg/mLJul 15, 2026Sep 2, 2026
HF Acquisition Co LLC, DBA HealthFirstPHYTONADIONE 10 mg/mLJul 15, 2026Sep 2, 2026
Hospira, Inc.PHYTONADIONE 2 mg/mLJul 15, 2026Sep 2, 2026
Hospira, Inc.PHYTONADIONE 10 mg/mLJul 15, 2026Sep 2, 2026
International Medication Systems, LimitedPHYTONADIONE 1 mg/.5mLJul 15, 2026Sep 2, 2026
Orbicular Pharmaceutical Technologies Private LimitedPHYTONADIONE 1 mg/.5mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsPHYTONADIONE 1 mg/.5mLJul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.PHYTONADIONE 1 mg/.5mLJul 15, 2026Sep 2, 2026
Xiromed LLCPHYTONADIONE 10 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Phytonadione — NDC 69097-0708-96," retrieved September 3, 2026, https://drugdashboards.com/drug/69097070896.

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