DrugDashboards

Lidocaine Hydrochloride and Epinephrine

LIDOCAINE HYDROCHLORIDE and EPINEPHRINE · EPINEPHRINE 5 ug/mL; LIDOCAINE HYDROCHLORIDE 15 mg/mL · Injection, Solution · Epidural · Hospira, Inc.

NDC 00409-1209-01 · 10 AMPULE in 1 TRAY / 5 mL in 1 AMPULE · ANDA · View full market →

The short version

Just 3 companies list this market (plus 3 repackagers, which add no supply) — thin enough that a single exit would be felt immediately. FDA lists this drug as in shortage right now (10 presentations or makers) — reason given: “other”.

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.

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.

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Estimated fill cost

WAC per package, as filed
$54.25
Reported to Texas DSHS · 2026 annual filing · Pfizer Inc. · package: 10 AMPULE in 1 TRAY / 5 mL in 1 AMPULE

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

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 over 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). Taken from CMS's own national row for the NDC (state code XX), which still counts the state-level cells CMS blanks for privacy (fewer than 11 prescriptions in a state-quarter); a quarter with fewer than 11 prescriptions nationally is blanked even there. The prescription count is CMS's Number of Prescriptions. To check: filter the SDUD file for the year to this NDC and State = XX 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.

$1,153
298 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

Not scored — fragility is computed for NDCs that have a NADAC price and a generic name.

90-day shortage risk (model v2)

0.4%chance of a new FDA shortage posting for lidocaine hydrochloride and epinephrine (injectable) in the next 90 days

sterile injectable

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 →

ⓘ 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.

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
ANDA088571
TE code
AP
Approval date
Sep 13, 1985
Patents / exclusivity
None on file
ⓘ How this was built
Data sources
  • FDA Orange Book data files — patent and exclusivity tables for application ANDA088571, 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 — Lidocaine Hydrochloride And Epinephrine, Injection, 1 g/50 mL (2%; 1:100,000) (NDC 0409-3182-03)Feb 22, 2012
    Other
    month 175 — 9× the typical 20-month injectable shortage
  • In shortage now — Lidocaine Hydrochloride And Epinephrine, Injection, 2.5 g/50 mL (0.5%; 1:200,000) (NDC 0409-3177-01)Feb 22, 2012
    Other
    month 175 — 9× the typical 20-month injectable shortage
  • In shortage now — Lidocaine Hydrochloride And Epinephrine, Injection, 200 mg/20 mL (1%; 1:100,000) (NDC 0409-3178-01)Feb 22, 2012
    Other
    month 175 — 9× the typical 20-month injectable shortage
  • In shortage now — Lidocaine Hydrochloride And Epinephrine, Injection, 300 mg/30 mL (1%; 1:100,000) (NDC 0409-3178-02)Feb 22, 2012
    Other
    month 175 — 9× the typical 20-month injectable shortage
  • In shortage now — Lidocaine Hydrochloride And Epinephrine, Injection, 400 mg/20 mL (2%; 1:100,000) (NDC 0409-3182-01)Feb 22, 2012
    Other
    month 175 — 9× the typical 20-month injectable shortage
  • In shortage now — Lidocaine Hydrochloride And Epinephrine, Injection, 400 mg/20 mL (2%; 1:200,000) (NDC 0409-3183-01)Feb 22, 2012
    month 175 — 9× the typical 20-month injectable shortage
  • In shortage now — Lidocaine Hydrochloride And Epinephrine, Injection, 450 mg/30 mL (1.5%; 1:200,000) (NDC 0409-3181-01)Feb 22, 2012
    month 175 — 9× the typical 20-month injectable shortage
  • In shortage now — Lidocaine Hydrochloride And Epinephrine, Injection, 500 mg/50 mL (1%; 1:100,000) (NDC 0409-3178-03)Feb 22, 2012
    month 175 — 9× the typical 20-month injectable shortage
  • In shortage now — Lidocaine Hydrochloride and Epinephrine, Injection, 600 mg/30 mL (2%; 1:100,000) (NDC 0409-3182-02)Feb 22, 2012
    Other
    month 175 — 9× the typical 20-month injectable shortage
  • In shortage now — Lidocaine Hydrochloride And Epinephrine, Injection, 75 mg/5 mL (1.5%; 1:200,000) (NDC 0409-1209-01)Feb 22, 2012
    Other
    month 175 — 9× the typical 20-month injectable shortage
Archived episodes (FDA list history via Wayback, 2019+)
  • In shortage now — Fresenius Kabi USA, Xylocaine 0.5% w/EPI 10 mL, 10 mg MDV (NDC 63323-481-57) (listed as “Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine”)Oct 14, 2016 → last seen May 14, 2023
  • In shortage now — Fresenius Kabi USA, Xylocaine 2% w/EPI 10 mL, 200 mg, SDV, MPF (NDC 63323-489-17) (listed as “Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine”)Oct 14, 2016 → last seen May 14, 2023
  • In shortage now — Fresenius Kabi USA, Xylocaine 1.5% w/EPI 10 mL, 150 mg, SDV, MPF (NDC 63323-488-17) (listed as “Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine”)Oct 14, 2016 → last seen May 14, 2023
  • In shortage now — Fresenius Kabi USA, Xylocaine 1% w/EPI 10 mL, 100 mg SDV, MPF (NDC 63323-487-17) (listed as “Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine”)Oct 14, 2016 → last seen May 14, 2023
  • In shortage now — Fresenius Kabi USA, Xylocaine 1% w/EPI 10 mL, 100 mg MDV (NDC 63323-482-17) (listed as “Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine”)Oct 14, 2016 → last seen May 14, 2023
  • In shortage now — Fresenius Kasbi USA, Xylocaine 2% w/EPI 20 ml, 400 mg SDV, MPF (NDC 63323-489-27) (listed as “Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine”)Oct 14, 2016 → last seen May 14, 2023
  • In shortage now — Fresenius Kabi USA, Xylocaine 1.5% w/EPI 30 mL, 450 mg, SDV, MPF (NDC 63323-488-37) (listed as “Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine”)Oct 14, 2016 → last seen May 14, 2023
  • In shortage now — Fresenius Kabi USA, Xylocaine 1% w/EPI 30 mL, 300 mg, SDV MPF (NDC 63323-487-37) (listed as “Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine”)Oct 14, 2016 → last seen May 14, 2023

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 LIDOCAINE HYDROCHLORIDE and EPINEPHRINE (Injection, Solution)

6 labelers active in the last 30 days, of which 3 are repackagers; 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.

LabelerStrengthsFirst seenLast seen
Henry Schein, Inc.repackagerEPINEPHRINE 10 ug/mL; LIDOCAINE HYDROCHLORIDE 10 mg/mL; EPINEPHRINE 10 ug/mL; LIDOCAINE HYDROCHLORIDE 20 mg/mL; EPINEPHRINE 5 ug/mL; LIDOCAINE HYDROCHLORIDE 5 mg/mL (+9 more)Jul 15, 2026Sep 4, 2026
Hospira, Inc.EPINEPHRINE 10 ug/mL; LIDOCAINE HYDROCHLORIDE 10 mg/mL; EPINEPHRINE 5 ug/mL; LIDOCAINE HYDROCHLORIDE 15 mg/mL; EPINEPHRINE 10 ug/mL; LIDOCAINE HYDROCHLORIDE 20 mg/mL (+7 more)Jul 15, 2026Sep 4, 2026
Septodont, Inc.EPINEPHRINE BITARTRATE .01 mg/mL; LIDOCAINE HYDROCHLORIDE 20 mg/mL; EPINEPHRINE BITARTRATE .02 mg/mL; LIDOCAINE HYDROCHLORIDE 20 mg/mL; EPINEPHRINE BITARTRATE 20 mg/mL; LIDOCAINE HYDROCHLORIDE .01 mg/mL (+1 more)Jul 15, 2026Sep 4, 2026
Cardinal Health 107, LLCrepackagerEPINEPHRINE 10 ug/mL; LIDOCAINE HYDROCHLORIDE 10 mg/mL; EPINEPHRINE 10 mg/mL; LIDOCAINE HYDROCHLORIDE 10 ug/mLJul 15, 2026Sep 2, 2026
ProPharma DistributionrepackagerEPINEPHRINE 10 ug/mL; LIDOCAINE HYDROCHLORIDE 20 mg/mL; EPINEPHRINE 20 mg/mL; LIDOCAINE HYDROCHLORIDE 10 ug/mLJul 15, 2026Sep 2, 2026
Sportpharm LLCEPINEPHRINE 10 ug/mL; LIDOCAINE HYDROCHLORIDE 10 mg/mL; EPINEPHRINE 10 mg/mL; LIDOCAINE HYDROCHLORIDE 10 ug/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Lidocaine Hydrochloride and Epinephrine — NDC 00409-1209-01," retrieved September 4, 2026, https://drugdashboards.com/drug/00409120901.

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