DrugDashboards

Cyanokit

Hydroxocobalamin · HYDROXOCOBALAMIN 5 g/250mL · Injection, Powder, Lyophilized, For Solution · Intravenous · Btg International Inc.

NDC 50633-0310-11 · 1 VIAL, GLASS in 1 CARTON / 250 mL in 1 VIAL, GLASS · NDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. It is in shortage right now — FDA lists the reason as “other.

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
$1,048.00
Reported to Texas DSHS · 2026 annual filing · BTG International Inc.

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

Supply fragility

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

90-day shortage risk (model v2)

0.4%chance of a new FDA shortage posting for hydroxocobalamin (injectable) in the next 90 days

sterile injectable · sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is 3× that.

Backtested statistical model over the whole market, not this package alone. Model details →

Where it's made

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

Regulatory

Application
NDA022041
TE code
Approval date
Dec 15, 2006
Patents / exclusivity
None on file

Shortage history

  • In shortage now Cyanokit, Injection, 5 g/250mL (NDC 50633-310-11)Nov 4, 2024
    Other
    month 22 of a typical 20 for injectable shortages · model puts 43% odds it resolves within 6 months

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Hydroxocobalamin (Injection, Powder, Lyophilized, For Solution)

LabelerStrengthFirst seenLast seen
Btg International Inc.HYDROXOCOBALAMIN 5 g/250mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Cyanokit — NDC 50633-0310-11," retrieved September 3, 2026, https://drugdashboards.com/drug/50633031011.

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