DrugDashboards

Elcys

Cysteine Hydrochloride · CYSTEINE HYDROCHLORIDE 10 mg/mL · Injection, Solution · Intravenous · Exela Pharma Sciences, LLC

NDC 51754-1007-03 · 100 mL in 1 CARTON · NDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. One of its named manufacturing plants, Exela Pharma Sciences, LLC., failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

  • Federal ceiling (Big4)$691.72per package of 10X10MLExela Pharma Sciences, LLC · Jan 1, 2026
  • List price (WAC, as filed)$947.03per packageExela Pharma Sciences · Jan 1, 2023

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
$947.03
Reported to Texas DSHS · 2026 annual filing · Exela Pharma Sciences

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

Medicaid spend (2025)

$912,978
680 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
NDA210660
TE code
Approval date
Apr 16, 2019
Patents / exclusivity
16 patents, 0 exclusivities
TypeNumber / codeExpires
patent11510942Jan 15, 2039
patent11969439Jan 15, 2039
patent10478453Jan 15, 2039
patent10583155Jan 15, 2039
patent10653719Jan 15, 2039
patent10918662Jan 15, 2039
patent10905713Jan 15, 2039
patent10905714Jan 15, 2039
patent11684636Jan 15, 2039
patent10933089Jan 15, 2039
patent11826383Jan 15, 2039
patent11679125Jan 15, 2039

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class I · OngoingOct 18, 2023
    Exela Pharma Sciences LLCPresence of Particulate Matter: Silicone

Manufacturers of Cysteine Hydrochloride (Injection, Solution)

LabelerStrengthFirst seenLast seen
Exela Pharma Sciences, LLCCYSTEINE HYDROCHLORIDE 10 mg/mLJul 15, 2026Sep 2, 2026
Exela Pharma Sciences, LLCCYSTEINE HYDROCHLORIDE 50 mg/mLJul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Elcys — NDC 51754-1007-03," retrieved September 3, 2026, https://drugdashboards.com/drug/51754100703.

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