Bupivacaine Hydrochloride and Epinephrine

Bupivacaine Hydrochloride And Epinephrine · BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL; EPINEPHRINE BITARTRATE 5 ug/mL · Injection, Solution · Epidural; Infiltration; Intracaudal; Perineural · Hospira, Inc.

NDC 00409-9042-01 · 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE · ANDA · View full market →

The short version

Only one company currently lists this market in the FDA directory (plus 1 repackager, which add no supply) — there is no backup if it stumbles. FDA lists this drug as in shortage right now (6 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

$64.15

Reported to Texas DSHS · 2026 annual filing · Pfizer Inc. · package: 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE

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.

$16,746

392 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.

Where it's made

Hospira, Inc.United States
analysis · label · manufacture · pack
Hospira, Inc.not a makerUnited States
analysis

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 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: ANDA071165
TE code: —
Approval date: Jun 16, 1988
Patents / exclusivity: None on file

ⓘ How this was built

Data sources

FDA Orange Book data files — patent and exclusivity tables for application ANDA071165, 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 — 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

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

In shortage now — Fresenius Kabi USA, LLC, Sensorcaine w/EPI 0.25% (125 mg per 50 mL) (2.5 mg per mL) MDV (NDC 63323-461-57) (listed as “Bupivacaine Hydrochloride and Epinephrine Injection”)Feb 20, 2018 → last seen May 14, 2023
In shortage now — Hospira, Inc., a Pfizer company, Marcaine with Epinephrine 1:200,000 as the bitartrate 250 mg/50 mL (5 mg/mL 1:200,000); Multiple Dose Glass Fliptop Vial (NDC 00409-1755-50) (listed as “Bupivacaine Hydrochloride and Epinephrine Injection”)Feb 20, 2018 → last seen May 14, 2023
In shortage now — Hospira, Inc., a Pfizer company, Marcaine with Epinephrine 1:200,000 as the bitartrate 125 mg/50 mL (2.5 mg/mL 1:200,000); Multiple Dose Glass Fliptop Vial (NDC 00409-1752-50) (listed as “Bupivacaine Hydrochloride and Epinephrine Injection”)Feb 20, 2018 → last seen May 14, 2023
In shortage now — Hospira, Inc., a Pfizer company, Marcaine with Epinephrine 1:200,000 as the bitartrate 150 mg/30 mL (5 mg/mL 1:200,000); Single Dose Glass Fliptop Vial (NDC 00409-1749-29) (listed as “Bupivacaine Hydrochloride and Epinephrine Injection”)Feb 20, 2018 → last seen May 14, 2023
In shortage now — Hospira, Inc., a Pfizer company, Marcaine with Epinephrine 1:200,000 as the bitartrate 50 mg/10 mL (5 mg/mL 1:200,000); Single Dose Glass Fliptop Vial (NDC 00409-1749-10) (listed as “Bupivacaine Hydrochloride and Epinephrine Injection”)Feb 20, 2018 → last seen May 14, 2023
In shortage now — Hospira, Inc., a Pfizer company, Marcaine with Epinephrine 1:200,000 as the bitartrate 75 mg/30 mL (2.5 mg/mL 1:200,000); Single Dose Glass Fliptop Vial (NDC 00409-1746-30) (listed as “Bupivacaine Hydrochloride and Epinephrine Injection”)Feb 20, 2018 → last seen May 14, 2023
In shortage now — Hospira, Inc., a Pfizer company, Marcaine with Epinephrine 1:200,000 as the bitartrate 25 mg/10 mL (2.5 mg/mL 1:200,000); Single Dose Glass Fliptop Vial (NDC 00409-1746-10) (listed as “Bupivacaine Hydrochloride and Epinephrine Injection”)Feb 20, 2018 → last seen May 14, 2023
In shortage now — Hospira, Inc., a Pfizer company, 250 mg/50 mL (5 mg/mL); Multiple Dose Glass Fliptop Vial (NDC 00409-9046-01) (listed as “Bupivacaine Hydrochloride and Epinephrine Injection”)Feb 20, 2018 → 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.

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.

Labelers of Bupivacaine Hydrochloride And Epinephrine (Injection, Solution)

2 labelers active in the last 30 days, of which 1 is a repackager; 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
Hospira, Inc.	BUPIVACAINE HYDROCHLORIDE 5 mg/mL; EPINEPHRINE BITARTRATE .0091 mg/mL; BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL; EPINEPHRINE BITARTRATE .0091 mg/mL; BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL; EPINEPHRINE BITARTRATE 5 ug/mL (+1 more)	Jul 15, 2026	Sep 3, 2026
Henry Schein, Inc.repackager	BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL; EPINEPHRINE BITARTRATE 5 ug/mL	Jul 15, 2026	Sep 2, 2026

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

Cite this page

DrugDashboards, "Bupivacaine Hydrochloride and Epinephrine — NDC 00409-9042-01," retrieved September 4, 2026, https://drugdashboards.com/drug/00409904201.

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