DrugDashboards

Bupivacaine Hydrochloride and Epinephrine

Bupivacaine Hydrochloride And Epinephrine · BUPIVACAINE HYDROCHLORIDE 5 mg/mL; EPINEPHRINE BITARTRATE 5 ug/mL · Injection, Solution · Epidural; Intracaudal; Perineural · Hospira, Inc.

NDC 00409-9045-17 · 25 VIAL, SINGLE-DOSE in 1 TRAY / 30 mL in 1 VIAL, SINGLE-DOSE · ANDA · View full market →

The short version

Just 2 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 “other”.

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

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
$99.19
Reported to Texas DSHS · 2026 annual filing · Pfizer Inc.

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

Medicaid spend (2025)

$7,136
1,343 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
ANDA071168
TE code
AP
Approval date
Jun 16, 1988
Patents / exclusivity
None on file

Shortage history

  • In shortage now — Bupivacaine Hydrochloride and Epinephrine, Injection, 125 mg/50 mL (2.5 mg/mL) (NDC 0409-9043-01)Feb 20, 2018
    Other
    month 103 — 5× the typical 20-month injectable shortage
  • In shortage now — Bupivacaine Hydrochloride and Epinephrine, Injection, 150 mg/30 mL (5 mg/mL) (NDC 0409-9045-17)Feb 20, 2018
    Other
    month 103 — 5× the typical 20-month injectable shortage
  • In shortage now — Bupivacaine Hydrochloride And Epinephrine, Injection, 25 mg/10 mL (2.5 mg/mL) (NDC 0409-9042-01)Feb 20, 2018
    Other
    month 103 — 5× the typical 20-month injectable shortage
  • In shortage now — Bupivacaine Hydrochloride And Epinephrine, Injection, 250 mg/50 mL (5 mg/mL) (NDC 0409-9046-01)Feb 20, 2018
    Other
    month 103 — 5× the typical 20-month injectable shortage
  • In shortage now — Bupivacaine Hydrochloride And Epinephrine, Injection, 50 mg/10 mL (5 mg/mL) (NDC 0409-9045-01)Feb 20, 2018
    Other
    month 103 — 5× the typical 20-month injectable shortage
  • In shortage now — Bupivacaine Hydrochloride And Epinephrine, Injection, 75 mg/30 mL (2.5 mg/mL) (NDC 0409-9042-17)Feb 20, 2018
    Other
    month 103 — 5× the typical 20-month injectable shortage

Recalls (this NDC)

  • Class II · TerminatedApr 13, 2022
    Mckesson Medical-Surgical Inc. Corporate Office — cGMP deviations: Temperature abuse
  • Class I · TerminatedMay 3, 2021
    PFIZER, INC — Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
  • Class I · OngoingAug 4, 2016
    Hospira Inc., A Pfizer Company — Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
  • Class I · TerminatedApr 23, 2015
    Hospira Inc. — Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.
  • Class II · TerminatedSep 4, 2014
    Hospira Inc. — Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of the glass vial.
  • Class II · TerminatedFeb 10, 2014
    Hospira Inc. — Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial.
  • Class II · TerminatedOct 11, 2013
    Hospira Inc. — Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
  • Class II · TerminatedSep 5, 2013
    Hospira Inc. — Lack of Assurance of Sterility; potential for vial breakage
  • Class I · TerminatedJul 12, 2013
    Hospira Inc. — Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
  • Class I · TerminatedJul 12, 2013
    Hospira Inc. — Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.

Manufacturers of Bupivacaine Hydrochloride And Epinephrine (Injection, Solution)

LabelerStrengthFirst seenLast seen
Hospira, Inc.BUPIVACAINE HYDROCHLORIDE 5 mg/mL; EPINEPHRINE BITARTRATE .0091 mg/mLJul 15, 2026Sep 3, 2026
Henry Schein, Inc.BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL; EPINEPHRINE BITARTRATE 5 ug/mLJul 15, 2026Sep 2, 2026
Hospira, Inc.BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL; EPINEPHRINE BITARTRATE .0091 mg/mLJul 15, 2026Aug 31, 2026
Hospira, Inc.BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL; EPINEPHRINE BITARTRATE 5 ug/mLJul 15, 2026Aug 31, 2026
Hospira, Inc.BUPIVACAINE HYDROCHLORIDE 5 mg/mL; EPINEPHRINE BITARTRATE 5 ug/mLJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Bupivacaine Hydrochloride and Epinephrine — NDC 00409-9045-17," retrieved September 3, 2026, https://drugdashboards.com/drug/00409904517.

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