DrugDashboards

Fentanyl Citrate

Fentanyl Citrate · FENTANYL CITRATE 50 ug/mL · Injection · Intravenous · Hikma Pharmaceuticals USA Inc.

NDC 00641-6029-01 · 20 mL in 1 VIAL · NDA · View full market →

The short version

Just 3 companies supply this market — thin enough that a single exit would be felt immediately. It is in shortage right now — FDA lists the reason as “demand increase for the drug”.

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.

  • Medicare Part B pays (ASP+6%)$1.39per billing unit (0.1 MG)HCPCS J3010 · Jul 1, 2026
  • Part D plans paid (avg)$13.76per dosage unitgross, before rebates — matched by drug name · 2024

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
$11.00
Reported to Texas DSHS · 2026 annual filing · Hikma Pharmaceuticals USA Inc.

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

Medicare Part B (ASP)

Payment limit per 0.1 MG
$1.385
HCPCS J3010 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2025)

$68
61 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

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

90-day shortage risk (model v2)

0.7%chance of a new FDA shortage posting for fentanyl citrate (injectable) in the next 90 days

sterile injectable · price up 70% YoY · sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is 5× that.

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

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 3 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $1,737.20 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program · Opioid Analgesic REMS Shared System REMS

Regulatory

Application
NDA019101
TE code
AP
Approval date
Jul 11, 1984
Patents / exclusivity
None on file

Shortage history

  • In shortage now — Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6027-25)Dec 20, 2023
    Demand increase for the drug
    month 33 of a typical 20 for injectable shortages · model puts 25% odds it resolves within 6 months
  • In shortage now — Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6028-25)Dec 20, 2023
    month 33 of a typical 20 for injectable shortages · model puts 25% odds it resolves within 6 months
  • In shortage now — Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6029-25)Dec 20, 2023
    month 33 of a typical 20 for injectable shortages · model puts 25% odds it resolves within 6 months
  • In shortage now — Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6030-01)Dec 20, 2023
    Demand increase for the drug
    month 33 of a typical 20 for injectable shortages · model puts 25% odds it resolves within 6 months
  • In shortage now — Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6247-25)Dec 20, 2023
    month 33 of a typical 20 for injectable shortages · model puts 25% odds it resolves within 6 months

Recalls (this NDC)

  • Class III · TerminatedMay 13, 2015
    West-Ward Pharmaceutical Corp. — Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
  • Class III · TerminatedFeb 16, 2015
    West-Ward Pharmaceutical Corporation — Failed Impurities/Degradation Specifications; 12 month stability testing.

Manufacturers of Fentanyl Citrate (Injection)

LabelerStrengthFirst seenLast seen
Hikma Pharmaceuticals USA Inc.FENTANYL CITRATE 50 ug/mLJul 15, 2026Sep 3, 2026
Phlow Corp.FENTANYL CITRATE 50 ug/mLJul 15, 2026Sep 2, 2026
Civica, Inc.FENTANYL CITRATE 50 ug/mLJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Fentanyl Citrate — NDC 00641-6029-01," retrieved September 3, 2026, https://drugdashboards.com/drug/00641602901.

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