Quick answers
- What is Fosphenytoin sodium used for?
- The FDA-approved label (Cerebyx, Pfizer Laboratories Div Pfizer Inc, August 28, 2025) says: “CEREBYX is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. CEREBYX can also be substituted, short-term, for oral phenytoin. CEREBYX should be used only when oral phenytoin administration is not possible […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Fosphenytoin sodium have a boxed warning?
- Yes. The FDA label for Cerebyx has a boxed warning (“WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION RATES”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Fosphenytoin sodium?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Fosphenytoin sodium been recalled?
- FDA enforcement reports list 4 recalls of products of this medicine; the newest started May 2, 2014 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Fosphenytoin sodium?
- 8 companies list prescription products of Fosphenytoin sodium in the FDA NDC Directory, including Glenmark Pharmaceuticals Inc., USA, Pfizer Laboratories Div Pfizer Inc and Gland Pharma Limited.
What Fosphenytoin sodium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
CEREBYX is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. CEREBYX can also be substituted, short-term, for oral phenytoin. CEREBYX should be used only when oral phenytoin administration is not possible […]. …
— FDA label: Cerebyx, Pfizer Laboratories Div Pfizer Inc, effective August 28, 2025. Read the full label on DailyMed →
The FDA has 10 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. Its heading: WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION RATES
. Read it on the full label →
9 of 10 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection |
|---|---|
| Route | Intramuscular · Intravenous |
| Prescription products | 16 in the FDA NDC Directory |
| Brand names | Cerebyx |
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.
- Glenmark Pharmaceuticals Inc., USA3 products
- Pfizer Laboratories Div Pfizer Inc3 products
- Gland Pharma Limited2 products
- Amneal Pharmaceuticals LLC2 products
- West-Ward Pharmaceuticals Corp2 products
- Hikma Pharmaceuticals USA Inc.2 products
- Fresenius Kabi USA, LLC1 product
- Sagent Pharmaceuticals1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020450 CEREBYX | Parke Davis | August 5, 1996 | 29, latest April 28, 2022 2022: Labeling · 2021: Labeling · 2021: Labeling |
Generic approvals (5)
- ANDA077989Hikma · August 6, 2007
- ANDA078052Fresenius Kabi USA · August 6, 2007
- ANDA078476Amneal · March 18, 2008
- ANDA078765Hikma Farmaceutica · December 2, 2009
- ANDA214926Gland · October 13, 2023
Shortage status
The FDA drug shortage list does not show these products.
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.
-
May 2, 2014 · Class II · Terminated · D-1429-2014
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-10 — Fresenius Kabi USA, LLC
-
May 2, 2014 · Class II · Terminated · D-1428-2014
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-02 — Fresenius Kabi USA, LLC
-
April 13, 2012 · Class II · Terminated · D-1437-2012
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 mL Single Dose Vial, packaged in 25-count x 2 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Portugal), S.A.; Dist. By: — West-ward Pharmaceutical Corp.
-
April 13, 2012 · Class II · Terminated · D-1438-2012
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10 mL Single Dose Vial, packaged in 10-count x 10 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Portugal), S.A.; Dist. B — West-ward Pharmaceutical Corp.
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) | 1670195, 1670197, 1670200, 1670201 |
|---|---|
| SPL set ID of the quoted label | d4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a |
| FDA labels (SPL) | 10 |
| FDA applications | NDA020450, 5 ANDA |
| Active ingredients (FDA) | FOSPHENYTOIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cerebyx, Pfizer Laboratories Div Pfizer Inc, effective August 28, 2025; 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 →