DrugDashboards

Xylocaine

Lidocaine Hydrochloride,epinephrine Bitartrate · LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mL; EPINEPHRINE BITARTRATE .01 mg/mL · Injection, Solution · Infiltration; Perineural · Fresenius Kabi USA, LLC

NDC 63323-0482-17 · 25 VIAL, MULTI-DOSE in 1 TRAY / 10 mL in 1 VIAL, MULTI-DOSE · NDA · View full market →

The short version

5 companies supply this market — a reasonable cushion if one runs into trouble. It is in shortage right now — FDA lists the reason as “demand increase for the drug”. 2 Class II recalls hit this product in the past year (Fresenius Kabi USA, LLC).

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.

  • Part D plans paid (avg)$0.2338per dosage unitgross, before rebates — matched by drug name · 2024
  • Federal ceiling (Big4)$60.79per package of 25X10MLFresenius Kabi, LLC · Jan 1, 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

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

Estimated fill cost

WAC per package, as filed
$99.00
Reported to Texas DSHS · 2026 annual filing · Fresenius Kabi USA

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

Medicaid spend (2025)

$46,343
3,007 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 · avg $10.16 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA006488
TE code
AP
Approval date
Jan 1, 1982
Patents / exclusivity
None on file

Shortage history

  • In shortage now — Xylocaine, Injection, .005 mg/1 mL; 15 mg/1 mL (NDC 63323-488-17)Oct 14, 2016
    Demand increase for the drug
    month 119 — 6× the typical 20-month injectable shortage · model puts 21% odds it resolves within 6 months
  • In shortage now — Xylocaine, Injection, .005 mg/1 mL; 15 mg/1 mL (NDC 63323-488-37)Oct 14, 2016
    month 119 — 6× the typical 20-month injectable shortage · model puts 21% odds it resolves within 6 months
  • In shortage now — Xylocaine, Injection, .005 mg/1 mL; 20 mg/1 mL (NDC 63323-489-17)Oct 14, 2016
    month 119 — 6× the typical 20-month injectable shortage · model puts 21% odds it resolves within 6 months
  • In shortage now — Xylocaine, Injection, .005 mg/1 mL; 20 mg/1 mL (NDC 63323-489-27)Oct 14, 2016
    Other
    month 119 — 6× the typical 20-month injectable shortage · model puts 21% odds it resolves within 6 months
  • In shortage now — Xylocaine, Injection, .005 mg/1 mL; 5 mg/1 mL (NDC 63323-481-57)Oct 14, 2016
    Demand increase for the drug
    month 119 — 6× the typical 20-month injectable shortage · model puts 21% odds it resolves within 6 months
  • In shortage now — Xylocaine, Injection, .01 mg/1 mL; 10 mg/1 mL (NDC 63323-482-17)Oct 14, 2016
    Demand increase for the drug
    month 119 — 6× the typical 20-month injectable shortage · model puts 21% odds it resolves within 6 months
  • In shortage now — Xylocaine, Injection, .01 mg/1 mL; 10 mg/1 mL (NDC 63323-482-27)Oct 14, 2016
    month 119 — 6× the typical 20-month injectable shortage · model puts 21% odds it resolves within 6 months
  • In shortage now — Xylocaine, Injection, .01 mg/1 mL; 10 mg/1 mL (NDC 63323-482-57)Oct 14, 2016
    Other
    month 119 — 6× the typical 20-month injectable shortage · model puts 21% odds it resolves within 6 months
  • In shortage now — Xylocaine, Injection, .01 mg/1 mL; 20 mg/1 mL (NDC 63323-483-27)Oct 14, 2016
    month 119 — 6× the typical 20-month injectable shortage · model puts 21% odds it resolves within 6 months
  • In shortage now — Xylocaine, Injection, .01 mg/1 mL; 20 mg/1 mL (NDC 63323-483-57)Oct 14, 2016
    month 119 — 6× the typical 20-month injectable shortage · model puts 21% odds it resolves within 6 months

Recalls (this NDC)

  • Class II · OngoingJul 16, 2026
    Fresenius Kabi USA, LLC — Presence of Particulate Matter: Hair was found in products
  • Class II · OngoingJul 16, 2026
    Fresenius Kabi USA, LLC — Presence of Particulate Matter: Hair was found in products
  • Class II · TerminatedApr 13, 2022
    Mckesson Medical-Surgical Inc. Corporate Office — cGMP deviations: Temperature abuse
  • Class II · TerminatedApr 13, 2022
    Mckesson Medical-Surgical Inc. Corporate Office — cGMP deviations: Temperature abuse
  • Class II · TerminatedJun 25, 2021
    Fresenius Kabi USA LLC — Low out of specification results for epinephrine assay.

Manufacturers of Lidocaine Hydrochloride,epinephrine Bitartrate (Injection, Solution)

LabelerStrengthFirst seenLast seen
A-S Medication SolutionsLIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL; EPINEPHRINE BITARTRATE .01 mg/mLAug 26, 2026Sep 2, 2026
Fresenius Kabi USA, LLCLIDOCAINE HYDROCHLORIDE ANHYDROUS 15 mg/mL; EPINEPHRINE BITARTRATE .005 mg/mLAug 26, 2026Sep 2, 2026
Fresenius Kabi USA, LLCLIDOCAINE HYDROCHLORIDE ANHYDROUS 5 mg/mL; EPINEPHRINE BITARTRATE .005 mg/mLAug 26, 2026Sep 2, 2026
Fresenius Kabi USA, LLCLIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL; EPINEPHRINE BITARTRATE .01 mg/mLAug 26, 2026Sep 2, 2026
Fresenius Kabi USA, LLCLIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL; EPINEPHRINE BITARTRATE .005 mg/mLAug 26, 2026Sep 2, 2026
ProPharma DistributionLIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mL; EPINEPHRINE BITARTRATE .01 mg/mLAug 26, 2026Sep 2, 2026
Remedyrepack Inc.LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mL; EPINEPHRINE BITARTRATE .01 mg/mLAug 26, 2026Sep 2, 2026
Sportpharm LLCLIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mL; EPINEPHRINE BITARTRATE .01 mg/mLAug 26, 2026Sep 2, 2026
Fresenius Kabi USA, LLCLIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mL; EPINEPHRINE BITARTRATE .01 mg/mLAug 26, 2026Aug 31, 2026
Fresenius Kabi USA, LLCLIDOCAINE HYDROCHLORIDE ANHYDROUS .01 mg/mL; EPINEPHRINE BITARTRATE 10 mg/mLJul 22, 2026Aug 21, 2026
A-S Medication SolutionsLIDOCAINE HYDROCHLORIDE ANHYDROUS .01 mg/mL; EPINEPHRINE BITARTRATE 20 mg/mLJul 22, 2026Aug 19, 2026
Fresenius Kabi USA, LLCLIDOCAINE HYDROCHLORIDE ANHYDROUS .005 mg/mL; EPINEPHRINE BITARTRATE 5 mg/mLJul 22, 2026Aug 19, 2026
Fresenius Kabi USA, LLCLIDOCAINE HYDROCHLORIDE ANHYDROUS .005 mg/mL; EPINEPHRINE BITARTRATE 20 mg/mLJul 22, 2026Aug 19, 2026
Fresenius Kabi USA, LLCLIDOCAINE HYDROCHLORIDE ANHYDROUS .005 mg/mL; EPINEPHRINE BITARTRATE 15 mg/mLJul 22, 2026Aug 19, 2026
Fresenius Kabi USA, LLCLIDOCAINE HYDROCHLORIDE ANHYDROUS .01 mg/mL; EPINEPHRINE BITARTRATE 20 mg/mLJul 22, 2026Aug 19, 2026
ProPharma DistributionLIDOCAINE HYDROCHLORIDE ANHYDROUS .01 mg/mL; EPINEPHRINE BITARTRATE 10 mg/mLJul 22, 2026Aug 19, 2026
Remedyrepack Inc.LIDOCAINE HYDROCHLORIDE ANHYDROUS .01 mg/mL; EPINEPHRINE BITARTRATE 10 mg/mLJul 22, 2026Aug 19, 2026
Sportpharm LLCLIDOCAINE HYDROCHLORIDE ANHYDROUS .01 mg/mL; EPINEPHRINE BITARTRATE 10 mg/mLJul 22, 2026Aug 19, 2026
Fresenius Kabi USA, LLCEPINEPHRINE BITARTRATE .01 mg/mL; LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mLJul 15, 2026Jul 18, 2026
A-S Medication SolutionsEPINEPHRINE BITARTRATE .01 mg/mL; LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mLJul 15, 2026Jul 15, 2026
Fresenius Kabi USA, LLCEPINEPHRINE BITARTRATE .005 mg/mL; LIDOCAINE HYDROCHLORIDE ANHYDROUS 15 mg/mLJul 15, 2026Jul 15, 2026
Fresenius Kabi USA, LLCEPINEPHRINE BITARTRATE .01 mg/mL; LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mLJul 15, 2026Jul 15, 2026
Fresenius Kabi USA, LLCEPINEPHRINE BITARTRATE .005 mg/mL; LIDOCAINE HYDROCHLORIDE ANHYDROUS 5 mg/mLJul 15, 2026Jul 15, 2026
Fresenius Kabi USA, LLCEPINEPHRINE BITARTRATE .005 mg/mL; LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mLJul 15, 2026Jul 15, 2026
ProPharma DistributionEPINEPHRINE BITARTRATE .01 mg/mL; LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mLJul 15, 2026Jul 15, 2026
Remedyrepack Inc.EPINEPHRINE BITARTRATE .01 mg/mL; LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mLJul 15, 2026Jul 15, 2026
Sportpharm LLCEPINEPHRINE BITARTRATE .01 mg/mL; LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mLJul 15, 2026Jul 15, 2026

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

Cite this page

DrugDashboards, "Xylocaine — NDC 63323-0482-17," retrieved September 3, 2026, https://drugdashboards.com/drug/63323048217.

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