Fentanyl Citrate

Fentanyl Citrate · FENTANYL CITRATE .05 mg/mL · Injection, Solution · Intramuscular; Intravenous · Fresenius Kabi USA, LLC

NDC 63323-0806-02 · 25 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE · ANDA · View full market →

The short version

Just 3 companies list this market — thin enough that a single exit would be felt immediately. The price has jumped 123% in a year, to $1.73 per mL — sharp rises like this often mean supply is already tightening. FDA lists this drug as in shortage right now (11 presentations or makers) — reason given: “other”. Put together: worth watching — several of the pressures that precede supply trouble are present at once.

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

ⓘ How this was built

Data sources

FDA NDC Directory (openFDA) — labelers active in the last 30 days, repackagers classified from DailyMed SPL establishment roles
CMS NADAC — latest price vs the price in effect ~12 months earlier
FDA drug shortages and enforcement reports (openFDA)
FDA inspection classifications; DrugDashboards fragility score and 90-day shortage model

Method

Each sentence is a template that fires only when its condition holds in the data shown lower on this page: maker counts are distinct FDA labelers listing this molecule and dosage form in the last 30 days minus classified repackagers; the price trend compares the newest NADAC with the last price in effect at least 9 months earlier; shortage and recall sentences restate FDA rows for this drug's presentations (Class I/II, trailing 12 months); the plant sentence needs a MANUFACTURE-role establishment with a drug-quality OAI in 24 months; the verdict restates the fragility band; the risk sentence appears only when the model's probability is at least 1.5× the typical market. Nothing here is inferred beyond those rules.

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

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 weekly file (pharmacy acquisition, per unit)
CMS Part B ASP quarterly payment limit file + NDC–HCPCS crosswalk
CMS Maximum Fair Prices (IRA negotiated), matched on the NDC-9
CMS Part D Spending by Drug (annual, name-matched, gross incl. dispensing fee)
CMS Part D plan formulary/pricing files (SPUF): point-of-sale price across plans
VA FSS / Big4 federal contract prices (per package; per unit when the package is a count above 1)
CMS Federal Upper Limits + weighted AMP for the multiple-source drug group (monthly)
Texas DSHS annual WAC catalog, then Texas/California increase filings (per package)

Method

Each rung is the newest figure for this NDC from one price system, shown with its own unit — units differ, so compare a rung over time, not rung against rung. Part B is the file's payment limit (typically ASP+6%, WAC+3% for new drugs; sequestration is applied at claim level); when the NDC maps to several HCPCS codes the lowest code is shown and the count noted. Part D average is shown only on an exact brand-name match or a generic name with a single CMS row. FSS keeps the lowest active contract price, Big4 first, and skips 1¢ placeholders. The FUL belongs to the whole multiple-source group, so a brand NDC shows its generic group's ceiling. WAC is the Texas catalog's current list price, else the newest increase filing already in effect. To check a rung: open the named CMS/VA/state file for the date shown and find this NDC.

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

Pharmacies pay (NADAC)$1.73per MLinvoice-surveyed acquisition cost · Aug 19, 2026
Part B payment limit (typically ASP+6%)$1.39per billing unit (0.1 MG)HCPCS J3010 · Jul 1, 2026
Part D plans paid (avg)$13.76per dosage unitCMS row "Fentanyl Citrate", matched by brand name — gross incl. dispensing fee, before rebates · 2024
List price (WAC, as filed)$57.25per packageTexas DSHS annual report · Fresenius Kabi USA · 2026

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

ⓘ How this was built

Data sources

CMS NADAC weekly files (data.medicaid.gov), December 2024 onward
CMS NADAC per-year archive files, 2013 – November 2024, averaged per month
CMS Federal Upper Limit file — weighted average manufacturer price (WAMP) of the generic group (dashed line)

Method

One line, two regimes: before December 2024 each point is the average of that month's archived NADAC rows for this NDC; from December 2024 each point is a row from the weekly file, which CMS publishes only when the price changes, so the line holds flat until the next change and is extended to today when the last row is under 6 months old. Since the December 2024 file CMS computes generic NADAC as a 3-month moving average, so recent generic moves are smoothed and lag the market. The dashed WAMP is the manufacturer-side average for the whole multiple-source group, not this NDC alone. To check a point: open the NADAC file for that date on data.medicaid.gov and find this NDC.

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

31 price points · per MLSource: CMS NADAC — monthly means to Nov 2024, weekly file after

Estimated fill cost

WAC per package, as filed

$57.25

Reported to Texas DSHS · 2026 annual filing · Fresenius Kabi USA · package: 25 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE

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

Medicare Part B (ASP)

ⓘ How this was built

Data sources

CMS Medicare Part B ASP quarterly pricing file and NDC–HCPCS crosswalk

Method

The payment limit CMS publishes for each HCPCS billing code this NDC maps to in the newest quarter's crosswalk. The limit is ASP+6% for most codes, WAC+3% for newly launched drugs, and ASP plus 8% of the reference product's ASP for some biosimilars; the 2% sequestration reduction is applied at claim level and is not reflected here. The unit is the code's billing unit, not the package. To check: open the ASP pricing file and crosswalk for the quarter shown on cms.gov.

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

Payment limit per 0.1 MG

$1.385

HCPCS J3010 · Fentanyl citrate injection · Jul 1, 2026 quarter

Medicaid spend (2025)

ⓘ How this was built

Data sources

CMS State Drug Utilization Data (SDUD), data.medicaid.gov

Method

CMS's Medicaid Amount Reimbursed for this exact NDC, summed across every state and quarter of the period shown, fee-for-service and managed care together — the program's gross payment to pharmacies before manufacturer rebates (statutory rebates alone recover 23.1% or more of a brand's price). Cells CMS suppresses (fewer than 11 prescriptions in a state-quarter) are absent from the file, so totals for small drugs run low. The prescription count is CMS's Number of Prescriptions. To check: filter the SDUD file for the year to this NDC and sum the column.

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

$45,475

9,528 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

45● Elevated risk

The score is counting real pressure here. One of these alone is routine; it’s the combination that makes this market worth watching.

3 active labelers+10
in shortage now+25
sterile injectable+10

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 4, 2026

ⓘ How this was built

Data sources

FDA NDC Directory (openFDA) — labelers active in the last 30 days, repackagers excluded via DailyMed SPL roles
FDA drug shortages and enforcement reports (openFDA)
CMS NADAC weekly file — price now vs the price in effect a year ago

Method

Fragility v1 adds fixed points per condition for this NDC's molecule × dosage form: active labelers minus repackagers (1 → +30, 2 → +20, 3 → +10, 4–5 → +5; unknown count → 0); shortage (this NDC listed Current +25, another presentation of the same molecule/form +15, a resolution within 12 months +8); Class I/II recalls in 12 months (this NDC +15, same molecule/form +8); NADAC down 40%+ year over year +15 or 20%+ +8 (a Medicare-negotiated price cut also trips this); sterile injectable form or intravenous route +10; a to-be-discontinued FDA listing +10; capped at 100. Every point shows as a line above. To check: count the molecule's labelers in the NDC Directory, then look it up in FDA's shortage list, openFDA enforcement, and two NADAC files a year apart.

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

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

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 →

ⓘ How this was built

Data sources

FDA NDC Directory labeler counts, CMS NADAC price trend, openFDA shortages and enforcement, FDA inspection classifications, Wayback archive of FDA's shortage list (labels)

Method

A logistic regression over molecule × dosage-form markets, trained on a monthly grid of historical dates since 2019 with labels equal to whether a new FDA shortage posting appeared within the following 90 days; eight features knowable on each date (labeler count, sole-source flag, NADAC year-over-year change, Class I/II recalls, injectable form, discontinuation filings, open shortage episodes, recent OAI inspection). The probability shown is the model's output for today's feature values; the reasons are the features pushing this market's probability up, listed only when the feature actually holds here. Held-out performance and coefficients are on the fragility page.

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

Where it's made

Fresenius Kabi USA, LLCUnited States
analysis · manufacture

Establishments this product's FDA label declares, with the role the label gives each (manufacture, API manufacture, pack, label, repack, analysis), located via FDA registration data. How we built this →

ⓘ How this was built

Data sources

DailyMed SPL labels (human prescription full release, monthly) — establishment DUNS and operations per label
FDA Drug Establishments Current Registration Site (DECRS) — DUNS to name and country
FDA Data Dashboard inspection classifications (Drug Quality Assurance)

Method

The label for this product's NDC-9 names each establishment and its operations; those DUNS numbers are matched to FDA's registration list for name and country. Only rows with a MANUFACTURE or API MANUFACTURE operation are places the drug is made; repack, relabel, pack, label and analysis rows are shown as what they are. The OAI badge means a drug-quality (GMP) inspection at that facility ended in Official Action Indicated within 24 months. Labels list plants, not volumes — a drug with two named plants may be made almost entirely at one. To check: open the label on DailyMed and its establishment section.

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

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: ANDA210762
TE code: AP
Approval date: May 3, 2019
Patents / exclusivity: None on file

ⓘ How this was built

Data sources

FDA Orange Book data files — patent and exclusivity tables for application ANDA210762, edition retrieved 2026-08-24

Method

Rows are the Orange Book's patent and exclusivity listings for this NDA, de-duplicated across product numbers (the file repeats a listing for every strength). A listed patent is a claim the sponsor filed; it may cover a use rather than the molecule, may be challenged, and may be delisted — a listing is not proof a generic is blocked. Pediatric extensions appear as *PED rows. FDA blocks automated downloads of the Orange Book from cloud servers, so the edition can trail FDA's monthly release; the retrieval date above is the edition shown. To check: search the application number on FDA's Orange Book site.

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

Shortage history

ⓘ How this was built

Data sources

FDA drug shortages via openFDA (current file: Current, To Be Discontinued, and recently Resolved rows)
Internet Archive (Wayback) snapshots of FDA's shortage list since 2019, reconstructed into episodes
DrugDashboards Kaplan–Meier duration curves and conditional duration model

Method

Top rows are FDA's live listings whose package NDC is this product or another package of the same generic name and dosage form. openFDA drops resolved rows after about six months, so older episodes come from monthly Wayback snapshots of FDA's file, matched on the molecule with dosage-form words stripped (that matching can pull in other salts or forms of the same molecule — the presentation is shown so you can tell). 'Month N of a typical M' compares this episode's age with the Kaplan–Meier median for its form class (injectable, oral solid, other) over episodes since October 2019, open episodes censored; the resolution odds come from a model conditioned on the episode's age and reason. To check: FDA's drug shortage database, and web.archive.org for its history.

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

In shortage now — Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-01)Jan 1, 2012
month 177 — 9× the typical 20-month injectable shortage · model puts 23% odds the market's longest-running episode resolves within 6 months
In shortage now — Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-02)Jan 1, 2012
month 177 — 9× the typical 20-month injectable shortage · model puts 23% odds the market's longest-running episode resolves within 6 months
In shortage now — Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-05)Jan 1, 2012
month 177 — 9× the typical 20-month injectable shortage · model puts 23% odds the market's longest-running episode resolves within 6 months
In shortage now — Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-20)Jan 1, 2012
month 177 — 9× the typical 20-month injectable shortage · model puts 23% odds the market's longest-running episode resolves within 6 months
In shortage now — Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-50)Jan 1, 2012
month 177 — 9× the typical 20-month injectable shortage · model puts 23% odds the market's longest-running episode resolves within 6 months
In shortage now — Fentanyl Citrate, Injection, 100 mcg/2 mL (50 ug/1 mL) (NDC 0409-9094-22)Jan 1, 2012
month 177 — 9× the typical 20-month injectable shortage · model puts 23% odds the market's longest-running episode resolves within 6 months
In shortage now — Fentanyl Citrate, Injection, 1000 mcg/20 mL (50 ug/1 mL) (NDC 0409-9094-31)Jan 1, 2012
Other
month 177 — 9× the typical 20-month injectable shortage · model puts 23% odds the market's longest-running episode resolves within 6 months
In shortage now — Fentanyl Citrate, Injection, 250 mcg/5 mL (50 ug/1 mL) (NDC 0409-9094-25)Jan 1, 2012
month 177 — 9× the typical 20-month injectable shortage · model puts 23% odds the market's longest-running episode resolves within 6 months
In shortage now — Fentanyl Citrate, Injection, 2500 mcg/50 mL (50 ug/1 mL) (NDC 0409-9094-61)Jan 1, 2012
month 177 — 9× the typical 20-month injectable shortage · model puts 23% odds the market's longest-running episode resolves within 6 months
In shortage now — Fentanyl Citrate, Injection, 50 ug/1 mL (NDC 63323-808-11)Jan 1, 2012
month 177 — 9× the typical 20-month injectable shortage · model puts 23% odds the market's longest-running episode resolves within 6 months
In shortage now — Fentanyl Citrate, Injection, 500 mcg/10 mL (50 ug/1 mL) (NDC 0409-9094-28)Jan 1, 2012
month 177 — 9× the typical 20-month injectable shortage · model puts 23% odds the market's longest-running episode resolves within 6 months

Archived episodes (FDA list history via Wayback, 2019+)

In shortage now — Hikma Pharmaceuticals USA, Inc., Fentanyl Citrate, Injection, 50 ug/1 mL (NDC 0641-6025-10) (listed as “Fentanyl Citrate Injection”)Dec 20, 2023 → last seen Jul 20, 2026
In shortage now — Hikma Pharmaceuticals USA, Inc., Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6247-25) (listed as “Fentanyl Citrate Injection”)Dec 20, 2023 → last seen Jul 20, 2026
In shortage now — Hikma Pharmaceuticals USA, Inc., Fentanyl Citrate, Injection, 50 ug/1 mL (NDC 0641-6026-05) (listed as “Fentanyl Citrate Injection”)Dec 20, 2023 → last seen Jul 20, 2026
In shortage now — Hikma Pharmaceuticals USA, Inc., Fentanyl Citrate, Injection, 50 ug/1 mL (NDC 0641-6024-10) (listed as “Fentanyl Citrate Injection”)Dec 20, 2023 → last seen Jul 20, 2026
In shortage now — Hikma Pharmaceuticals USA, Inc., Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6030-01) (listed as “Fentanyl Citrate Injection”)Dec 20, 2023 → last seen Jul 20, 2026
In shortage now — Hikma Pharmaceuticals USA, Inc., Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6027-25) (listed as “Fentanyl Citrate Injection”)Dec 20, 2023 → last seen Jul 20, 2026
In shortage now — Hikma Pharmaceuticals USA, Inc., Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6028-25) (listed as “Fentanyl Citrate Injection”)Dec 20, 2023 → last seen Jul 20, 2026
In shortage now — Hikma Pharmaceuticals USA, Inc., Fentanyl Citrate, Injection, 50 mcg/1 mL (NDC 0641-6029-25) (listed as “Fentanyl Citrate Injection”)Dec 20, 2023 → last seen Jul 20, 2026

Showing 8 of 30 archived episodes.

Recalls (this NDC)

ⓘ How this was built

Data sources

FDA drug enforcement reports via openFDA

Method

Enforcement reports whose product NDC list includes this exact package NDC, newest first, with FDA's classification (I = reasonable probability of serious harm, II = temporary or reversible harm, III = unlikely to cause harm) and the recall's current status. Reports for other packages of the same drug are not shown here; 275 of the last year's Class I/II reports carry no NDC at all and cannot be matched. To check: search the recall number on openFDA or FDA's enforcement reports.

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

No enforcement reports list this package NDC.

Labelers of Fentanyl Citrate (Injection, Solution)

3 labelers active in the last 30 days; 0not seen for 30+ days. Keyed on FDA's generic-name string — other salts or forms of the molecule are separate rosters.

ⓘ How this was built

Data sources

FDA NDC Directory (openFDA), read daily since 2026-07-15 — labeler_name per package
DailyMed SPL establishment roles + name patterns → derived.labeler_kinds (repackager / manufacturer / unknown)

Method

One row per labeler that lists any package with this exact generic-name string and dosage form; strengths are combined. 'First seen' is the first daily snapshot that contained the labeler here (2026-07-15 for everything present at the start), 'last seen' the most recent; a labeler counts as active when seen in the last 30 days. Repackagers and relabelers are flagged when their own labels show only repack/relabel operations or their name matches a known repackager, and are excluded from every 'makers' count on this page. Listing is not volume: a labeler with a listed NDC may ship little or nothing. To check: search the generic name in FDA's NDC Directory and list the labelers.

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

Labeler	Strengths	First seen	Last seen
Bond Pharmacy INC	FENTANYL CITRATE 10 mg/mL	Jul 15, 2026	Sep 2, 2026
Fresenius Kabi USA, LLC	FENTANYL CITRATE .05 mg/mL; FENTANYL CITRATE 100 ug/2mL; FENTANYL CITRATE 50 ug/mL	Jul 15, 2026	Sep 2, 2026
Hospira, Inc.	FENTANYL CITRATE 50 ug/mL	Jul 15, 2026	Aug 31, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 15, 2026.

Cite this page

DrugDashboards, "Fentanyl Citrate — NDC 63323-0806-02," retrieved September 4, 2026, https://drugdashboards.com/drug/63323080602.

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