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Palonosetron Hydrochloride Injection shortage

Palonosetron Hydrochloride Injection is currently listed in shortage by the FDA. The FDA lists 1 affected product. This page was last refreshed from FDA data on Oct 2, 2026.

To Be Discontinued ⚠ Supply risk: High Gastroenterology 1 product 322 days First posted Nov 14, 2025 Updated Nov 14, 2025
Here’s the bottom line

Teva is permanently stopping production of palonosetron hydrochloride injection 0.25 mg/5 mL. Other makers — including Sandoz, NorthStar Rx, Sagent, and Baxter — still list this medicine as available.

Don’t stop or change your therapy on your own — talk with your prescriber about the plan that fits you, and ask your pharmacist what’s actually available (see options).

Do you take this drug? See the ‘What to do’ recommendation from Dr. Brian Staiger, PharmD →
1
Affected NDCs
1
Reporting manufacturers
0/1
Reporting mfrs supplying
0/1
Affected strengths supplied
322
Days in shortage
6,675
Medicaid Rx (2026)
Source: FDA Drug Shortages Database API (openFDA). Last refreshed Oct 2, 2026 · yesterday

What’s in shortage — at a glance

These figures count only the manufacturers that reported this shortage to the FDA — not every company that makes Palonosetron Hydrochloride Injection. Other makers that haven’t reported a problem are shown in the green card below.

Availability of affected NDCs
From the FDA shortage report
1 NDCs
To be discontinued 1
Affected strengths still supplied
Among manufacturers reporting this shortage
0/1 strengths
No supply 1
FDA-reporting manufacturers with supply
Among manufacturers reporting this shortage
0/1 makers
No supply 1
✓ Other manufacturers not reporting a shortage
Still-marketed Palonosetron Hydrochloride Injection from companies that have not filed an FDA shortage — these are not counted in the figures above. Stock can still vary by pharmacy.
Sandoz Inc NorthStar Rx LLC Sagent Pharmaceuticals Baxter Healthcare Corporation Dr.Reddy's Laboratories Limited Eugia US LLC Apotex Corp. Fresenius Kabi USA, LLC Mylan Institutional LLC BluePoint Laboratories Cipla USA Inc. Meitheal Pharmaceuticals Inc.
See all other options & details →
Shortage timeline
  1. Nov 14, 2025
    Currently in shortage
    1 of 1 product affected.
  2. Nov 14, 2025
    First reported to the FDA
    1 product first listed.

Built from FDA posting and update dates. The end date FDA publishes is the posting/update date, not a true resolution date, so durations are approximate.

What exactly is on backorder — by manufacturer

Manufacturer: Teva Pharmaceuticals USA, Inc. 📞 800-545-8800 1 NDC click to expand
Status NDC / product Strength Availability Related information Reason
To Be Discontinued Palonosetron Hydrochloride, Injection, .25 mg/5 mL (NDC 0703-4094-01) NDC 00703-4094-01 — — Discontinuation of the manufacture of the drug —

These rows are manufacturer reports to the FDA for Palonosetron Hydrochloride Injection — they do not necessarily cover every manufacturer that makes this drug. A company appears here only if it told the FDA it has a supply problem, so other makers may still have stock. That’s the basis for the Where else can I get Palonosetron Hydrochloride Injection? options further down this page.

Why is Palonosetron Hydrochloride Injection in shortage?

Teva Pharmaceuticals has reported to the FDA that they are permanently stopping the manufacturing of their version of palonosetron hydrochloride injection 0.25 mg/5 mL (the vial size). This means that particular product from Teva will no longer be produced going forward.

No specific reason was shared publicly by Teva for why they are making this decision — they simply reported the discontinuation to the FDA. It's also worth knowing that this report only reflects Teva's product. Other manufacturers of palonosetron injection are listed separately and are not part of this specific report.

Based on the manufacturer-reported reason(s) and notes on file with the FDA for Palonosetron Hydrochloride Injection, summarized in plain English by HelloPharmacist. A drug can be short for more than one reason, and the FDA updates these as manufacturers report changes.

What should I do if I take Palonosetron Hydrochloride Injection?

Palonosetron hydrochloride injection, a medicine used to help prevent nausea and vomiting, is currently on the FDA shortage list. I want to walk you through what this means so you can plan calmly.

The strength affected is the 0.25 mg/5 mL injection. Teva Pharmaceuticals has reported this product as to be discontinued — the reason given is that they are stopping its manufacture. Because this reflects Teva's decision, it means their supply may not return, though this record covers only that one maker. The good part to keep in mind: several other companies still list the same medicine, so it is not gone from the market as a whole.

Here is what I suggest:

  • Do not stop or change how you receive this medicine on your own. Since it is given by injection, your care team manages the dosing.
  • Ask your pharmacy or clinic to check whether the same medicine is available from another maker. From our records, Sandoz, Baxter, Eugia, Apotex, Fresenius Kabi, Mylan, Cipla, and Meitheal list the 0.25 mg/5 mL form. It may not be in local stock, but your pharmacy can check wholesalers.
  • Because Teva's version is being discontinued, ask your prescriber or pharmacist about the best next step, such as a clinician-chosen equivalent.

Manufacturer contact numbers are listed on this page for reference; pharmacies usually handle those calls. This is general national information and may not match your local stock.

See “Where else can I get Palonosetron Hydrochloride Injection?” below ↓ The same medicine from manufacturers not reporting a shortage, alternative dosage forms, and therapeutic equivalents with pricing.
If you are a patient:
  • Don’t stop or change the medication on your own — talk to your prescriber first.
  • If this is part of an ongoing or essential regimen (for example HIV treatment or prevention, seizure, heart, transplant, diabetes or mental-health medicines), do not skip or ration doses — contact your pharmacist or prescriber right away to arrange continued supply before you run out.
  • Ask your pharmacy to check other manufacturers, strengths, package sizes, and nearby stores.
  • Ask your prescriber whether a different strength, formulation, or the brand/generic version is appropriate.
Keep reading
Our full Palonosetron Injection guide

Uses, dosing, side effects, prices, and the complete FDA label — written in plain English and pharmacist-reviewed.

Read the Palonosetron Injection guide →

Where else can I get Palonosetron Hydrochloride Injection?

FDA shortages are manufacturer-reported — a company only shows up on the shortage list if it told the FDA it has a supply problem, so not every maker of Palonosetron Hydrochloride Injection is necessarily short. Below we pull together the other still-marketed options that are not reported in shortage: the same medicine from manufacturers that haven’t reported a problem, and alternative dosage forms. These may still be out of stock at your pharmacy, and only your prescriber or pharmacist can decide what’s right for you.

Same medicine, other manufacturers (not reported short)

Same active ingredient, dosage form & route as the shortage (matched on the FDB HICL ingredient code), from makers that have not filed a shortage with the FDA:

ProductStrengthForm / routeManufacturerNDC
Palonosetron Hydrochloride PALONOSETRON HYDROCHLORIDE .25 mg/5mL Injection, Solution · Intravenous Sandoz Inc 00781-3312-75
Palonosetron PALONOSETRON HYDROCHLORIDE .05 mg/mL Injection, Solution · Intravenous NorthStar Rx LLC 16714-0834-01
Palonosetron Hydrochloride PALONOSETRON HYDROCHLORIDE .05 mg/mL Injection, Solution · Intravenous Sagent Pharmaceuticals 25021-0783-05
Palonosetron Hydrochloride PALONOSETRON HYDROCHLORIDE .25 mg/5mL Injection · Intravenous Baxter Healthcare Corporation 36000-0326-02
Palonosetron PALONOSETRON HYDROCHLORIDE .05 mg/mL Injection, Solution · Intravenous Dr.Reddy's Laboratories Limited 55111-0694-07
Palonosetron Hydrochloride PALONOSETRON HYDROCHLORIDE .25 mg/5mL Injection, Solution · Intravenous Eugia US LLC 55150-0186-05
Palonosetron PALONOSETRON HYDROCHLORIDE .25 mg/5mL Injection · Intravenous Apotex Corp. 60505-6193-01
Palonosetron PALONOSETRON HYDROCHLORIDE .25 mg/5mL Injection, Solution · Intravenous Fresenius Kabi USA, LLC 63323-0673-05
Palonosetron Hydrochloride PALONOSETRON HYDROCHLORIDE .25 mg/5mL Injection, Solution · Intravenous Mylan Institutional LLC 67457-0317-25
Palonosetron PALONOSETRON HYDROCHLORIDE .05 mg/mL Injection, Solution · Intravenous BluePoint Laboratories 68001-0355-25
Palonosetron Hydrochloride PALONOSETRON HYDROCHLORIDE .25 mg/5mL Injection · Intravenous Cipla USA Inc. 69097-0927-35
Palonosetron Hydrochloride PALONOSETRON HYDROCHLORIDE .25 mg/5mL Injection, Solution · Intravenous Meitheal Pharmaceuticals Inc. 71288-0409-05
Therapeutic equivalents & pricing 19 productsclick to expand

Orange Book–rated equivalents of the affected strengths, with the latest NADAC price (a federal retail-acquisition benchmark, not your copay) and an evidence-based availability label. Cheapest first.

ProductManufacturerPackageNADAC $/unitAB ratingAvailability
Palonosetron Hydrochloride .25 mg/5mLNDC 00703-4094-01 Teva 1 vial — — FDA listed
Palonosetron Hydrochloride .25 mg/5mLNDC 00781-3312-75 Sandoz 1 vial — AP FDA listed
Palonosetron Hydrochloride .25 mg/5mLNDC 00781-3415-75 Sandoz 1 vial — AP Discontinued
Palonosetron .05 mg/mLNDC 16714-0834-01 NorthStar 1 vial — AP FDA listed
palonosetron hydrochloride .05 mg/mLNDC 25021-0783-05 Sagent 1 vial — AP FDA listed
Palonosetron Hydrochloride .25 mg/5mLNDC 36000-0326-02 Baxter 1 vial — — FDA listed
Palonosetron .05 mg/mLNDC 55111-0694-07 Dr.Reddy's 1 vial — AP FDA listed
Palonosetron Hydrochloride .25 mg/5mLNDC 55150-0186-05 Eugia 1 vial — AP FDA listed
Palonosetron .25 mg/5mLNDC 60505-6193-01 Apotex 1 vial — — FDA listed
Palonosetron .25 mg/5mLNDC 60505-6439-01 Apotex 1 vial — — FDA listed
Palonosetron .25 mg/5mLNDC 63323-0673-05 Fresenius 1 vial — AP FDA listed
Palonosetron .25 mg/5mLNDC 67184-0514-01 Qilu 1 vial — — FDA listed
Palonosetron Hydrochloride .25 mg/5mLNDC 67457-0317-25 Mylan 1 vial — AP FDA listed
Palonosetron .05 mg/mLNDC 68001-0355-25 BluePoint 1 vial — AP FDA listed
palonosetron hydrochloride .25 mg/5mLNDC 69097-0927-35 Cipla 1 vial — — FDA listed
Palonosetron Hydrochloride .25 mg/5mLNDC 71288-0409-05 Meitheal 1 vial — AP FDA listed
Palonosetron Hydrochloride .05 mg/mLNDC 83634-0777-05 Avenacy, 1 vial — — Discontinued
posfrea .25 mg/5mLNDC 83831-0105-01 Avyxa 1 vial — — FDA listed
Palonosetron .25 mg/5mLNDC 68001-0708-25 BLuePoint 1 vial — — FDA listed

Equivalents share the same ingredient, strength, dosage form and route; an AB rating means the FDA considers them substitutable. NADAC is a national retail-pharmacy acquisition benchmark from CMS — not what you pay. Availability is inferred from recent pricing, not a stock check.

Other drugs in the same treatment class

These are different medicines — not other versions of Palonosetron Hydrochloride Injection — that fall in the same broad treatment class (antiemetic/antivertigo agents) . They are not automatic substitutes: they can differ in how they work, dosing, effectiveness, side effects and what they’re approved to treat. Do not switch on your own. This list is for information only — ask your prescriber or pharmacist whether any of them is appropriate for you.

Identity & classification

GCN Seq No 052943
GCN 20228
HICL code 025512
Ingredient (HICL) Palonosetron Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6J
Therapeutic class — specific (HIC3) Antiemetic/Antivertigo Agents
AHFS code 56:22.20.00
AHFS class 5-Ht3 Receptor Antagonists
FDB label name PALONOSETRON 0.25 MG/5 ML VIAL
FDB brand name Palonosetron Hcl
Legend status F — Federal legend — prescription drug or device
GPI-1450250070102020
GPI classPalonosetron HCl
Where does this data come from?
Identity codes come from First Databank (FDB) (HICL ingredient, HIC1–3 therapeutic-class hierarchy, GCN, AHFS class, legend status) and Medi-Span GPI, mapped from a representative affected NDC. Licensed reference data — for identification only.

Other gastroenterology shortages

Palonosetron Hydrochloride Injection shortage FAQs

Is Palonosetron Hydrochloride Injection in shortage?
Yes — the FDA currently lists Palonosetron Hydrochloride Injection in shortage (status: “To Be Discontinued”, first reported Nov 14, 2025). 1 of 1 product is affected. This is national, manufacturer-reported data, so your pharmacy may still have stock.
Which products are affected?
Palonosetron Hydrochloride, Injection, .25 mg/5 mL (NDC 0703-4094-01) (NDC 00703-4094-01). The full per-NDC list (availability, manufacturer and status) is in the table above — each NDC links to its own page.
When will Palonosetron Hydrochloride Injection be available again?
The FDA does not publish a guaranteed restock date, and no estimated-recovery note is on file. Availability can change daily — confirm with your pharmacy.
Can I still get Palonosetron Hydrochloride somewhere?
Other manufacturers (Sandoz Inc, NorthStar Rx LLC, Sagent Pharmaceuticals and others) still market it and have not reported a shortage. See “Where else can I get Palonosetron Hydrochloride Injection?” above — stock still varies by pharmacy.
What should I do if I take Palonosetron Hydrochloride Injection?
Don’t stop or change it on your own. Ask your pharmacist whether they can order it from another manufacturer or a different strength/package size, and ask your prescriber about a long-term plan before your supply runs out.

Still have a question about the Palonosetron Hydrochloride Injection shortage?

Ask a pharmacist about this shortage →
How to read the Supply-Risk rating
Low (1–2)Multiple manufacturers still supplying and most strengths or pack sizes sourceable.
Medium (3)Some constraint — fewer suppliers or a notable share of NDCs unavailable.
High (4–5)Down to a single source, most strengths or pack sizes unsourceable, or a long-running outage.
Where does this data come from?
Shortage records come from the FDA Drug Shortages Database API via openFDA (/drug/shortages) — drug, manufacturer & contact, NDC/product, status, availability, reason, therapeutic category and posting/update dates. Current / To Be Discontinued = active; Resolved is kept for history. The Supply-Risk rating is assessed per active ingredient and adds the FDA NDC Directory (still-marketed manufacturers by ingredient & form); same-medicine and equivalent products use First Databank classification + CMS NADAC pricing; Medicaid use + most-affected states come from CMS Medicaid State Drug Utilization Data. Reference only — confirm current status with the manufacturer or FDA before acting on it.
Data structure & sourcing designed and verified by Dr. Brian Staiger, PharmD.
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