Quick answers
- What is Pralidoxime chloride used for?
- The FDA-approved label (Protopam Chloride, Baxter Healthcare Corporation, April 1, 2026) says: “PROTOPAM Chloride is indicated as an antidote: in the treatment of poisoning due to those pesticides and chemicals (e.g., nerve agents) of the organophosphate class which have anticholinesterase activity and in the control of overdosage by anticholinesterase drugs used in the treatment of myasthenia gravis. The principal indications for the use of PROTOPAM Chloride are muscle weakness and respiratory depression. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Pralidoxime chloride have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Pralidoxime chloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Pralidoxime chloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Pralidoxime chloride?
- 1 company lists prescription products of Pralidoxime chloride in the FDA NDC Directory, including Baxter Healthcare Corporation.
What Pralidoxime chloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
PROTOPAM Chloride is indicated as an antidote: in the treatment of poisoning due to those pesticides and chemicals (e.g., nerve agents) of the organophosphate class which have anticholinesterase activity and in the control of overdosage by anticholinesterase drugs used in the treatment of myasthenia gravis. The principal indications for the use of PROTOPAM Chloride are muscle weakness and respiratory depression. …
— FDA label: Protopam Chloride, Baxter Healthcare Corporation, effective April 1, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intramuscular · Intravenous · Subcutaneous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Protopam Chloride |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Baxter Healthcare Corporation1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA014134 PROTOPAM CHLORIDE | Baxter Hlthcare Corp | March 11, 1964 | 23, latest January 15, 2014 2014: Manufacturing (CMC) · 2013: Manufacturing (CMC) · 2012: Manufacturing (CMC) |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 208969, 312576 |
|---|---|
| SPL set ID of the quoted label | 2741d8fd-51c2-46be-880b-99f2b20a6137 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA014134 |
| Active ingredients (FDA) | PRALIDOXIME |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Protopam Chloride, Baxter Healthcare Corporation, effective April 1, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →