Quick answers
- What is Valproate sodium used for?
- The FDA-approved label (Valproate Sodium, Sagent Pharmaceuticals, March 12, 2026) says: “Valproate Sodium Injection is indicated as an intravenous alternative in patients in whom oral administration of valproate products is temporarily not feasible in the following conditions: Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Valproate sodium have a boxed warning?
- Yes. The FDA label for Valproate Sodium has a boxed warning (“WARNING: LIFE THREATENING ADVERSE REACTIONS WARNING: LIFE THREATENING ADVERSE REACTIONS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Valproate sodium?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 15, 2026). Ask your pharmacist about alternatives.
- Has Valproate sodium been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Valproate sodium?
- 3 companies list prescription products of Valproate sodium in the FDA NDC Directory, including Hikma Pharmaceuticals USA Inc., Fresenius Kabi USA, LLC and Sagent Pharmaceuticals.
What Valproate sodium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Valproate Sodium Injection is indicated as an intravenous alternative in patients in whom oral administration of valproate products is temporarily not feasible in the following conditions: Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures …
— FDA label: Valproate Sodium, Sagent Pharmaceuticals, effective March 12, 2026. Read the full label on DailyMed →
The FDA has 5 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.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
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: LIFE THREATENING ADVERSE REACTIONS WARNING: LIFE THREATENING ADVERSE REACTIONS
. Read it on the full label →
5 of 5 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 4 in the FDA NDC Directory |
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.
- Hikma Pharmaceuticals USA Inc.2 products
- Fresenius Kabi USA, LLC2 products
- Sagent Pharmaceuticals1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (3)
- ANDA076295Sagent · November 14, 2002
- ANDA076539Fresenius Kabi USA · June 26, 2003
- ANDA078523Hikma Farmaceutica · February 17, 2010
Shortage status
Current shortage · updated October 15, 2026 · first posted December 30, 2020
| Product | Valproate Sodium, Injection, 100 mg/1 mL (NDC 63323-494-05) |
|---|---|
| Availability | Unavailable |
| Reason given | Demand increase for the drug |
| Company | Fresenius Kabi USA, LLC |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1099648 |
|---|---|
| SPL set ID of the quoted label | 8d5fc1c1-d3c0-497e-971b-6c4dba9a3fad |
| FDA labels (SPL) | 5 |
| FDA applications | 3 ANDA |
| Active ingredients (FDA) | VALPROATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Valproate Sodium, Sagent Pharmaceuticals, effective March 12, 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 →