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Prescription medicine · generic available

Prochlorperazine

Brand names: Compro

Also listed by the FDA as: prochlorperazine maleate · prochlorperazine edisylate · prochlorperazine

Drug class: Phenothiazine

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

YesBoxed warning
None listedFDA shortage list
2Recalls (FDA reports)
45Companies
1989First FDA approval on file

Quick answers

What is Prochlorperazine used for?
The FDA-approved label (Compro, PD-Rx Pharmaceuticals, Inc., March 20, 2025) says: “Prochlorperazine 25 mg suppositories are indicated in the control of severe nausea and vomiting in adults.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Prochlorperazine have a boxed warning?
Yes. The FDA label for Compro has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
Is there a shortage of Prochlorperazine?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Prochlorperazine been recalled?
FDA enforcement reports list 2 recalls of products of this medicine; the newest started December 27, 2022 (Class III). A recall usually concerns specific lots, not every product.
Who makes Prochlorperazine?
45 companies list prescription products of Prochlorperazine in the FDA NDC Directory, including Remedyrepack Inc., Redpharm Drug and Bryant Ranch Prepack.

What Prochlorperazine is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Prochlorperazine 25 mg suppositories are indicated in the control of severe nausea and vomiting in adults.

— FDA label: Compro, PD-Rx Pharmaceuticals, Inc., effective March 20, 2025. Read the full label on DailyMed →

The FDA has 57 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

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.

This label has a boxed warning. Read it on the full label →

56 of 57 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet · Tablet, film coated · Injection · Suppository · Injection, solution
RouteOral · Intramuscular · Intravenous · Rectal
Prescription products84 in the FDA NDC Directory
Brand namesCompro

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Prochlorperazine, by strength and form
Strength and formGeneric or brandPharmacies pay
prochlorperazine 25 mg
suppository		 Generic $4.92 per suppository
prochlorperazine 25 mg
suppository		 Brand: Compro $6.77 per suppository
prochlorperazine maleate 10 mg
tablet		 Generic $0.1590 per tablet
prochlorperazine maleate 10 mg
tablet, film coated		 Generic $0.1590 per tablet
prochlorperazine maleate 5 mg
tablet		 Generic $0.1115 per tablet
prochlorperazine maleate 5 mg
tablet, film coated		 Generic $0.1115 per tablet

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

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.

FDA approval history

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (21)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. December 27, 2022 · Class III · Terminated · D-0096-2023

    Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.

    Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06 — Jubilant Cadista Pharmaceuticals, Inc.

  2. May 21, 2019 · Class I · Terminated · D-1397-2019

    Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .

    PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India. Mfg for: Heritage Pharmaceuticals Inc. NDC 23155-294-31 — Heritage Pharmaceuticals, Inc.

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)198159, 198365, 284254, 312635, 314192, 2102949
SPL set ID of the quoted labelb23b67eb-78b7-48eb-84ff-c95d3ce8683c
FDA labels (SPL)57
FDA applications21 ANDA
Active ingredients (FDA)PROCHLORPERAZINE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Compro, PD-Rx Pharmaceuticals, Inc., effective March 20, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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 →

Report an error → · Information for medicine makers