Quick answers
- What is Divalproex sodium used for?
- The FDA-approved label (Depakote, AbbVie Inc., March 31, 2026) says: “Depakote is an anti-epileptic drug indicated for: Treatment of manic episodes associated with bipolar disorder 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 Divalproex sodium have a boxed warning?
- Yes. The FDA label for Depakote has a boxed warning (“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 Divalproex sodium?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Divalproex sodium been recalled?
- FDA enforcement reports list 9 recalls of products of this medicine; the newest started June 26, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Divalproex sodium?
- 44 companies list prescription products of Divalproex sodium in the FDA NDC Directory, including Remedyrepack Inc., Bryant Ranch Prepack and American Health Packaging.
What Divalproex sodium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Depakote is an anti-epileptic drug indicated for: Treatment of manic episodes associated with bipolar disorder Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures …
— FDA label: Depakote, AbbVie Inc., effective March 31, 2026. Read the full label on DailyMed →
The FDA has 118 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
. Read it on the full label →
116 of 118 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, delayed release · Tablet, film coated, extended release · Tablet, extended release · Capsule, coated pellets · Capsule, delayed release · Capsule |
|---|---|
| Route | Oral |
| Prescription products | 182 in the FDA NDC Directory |
| Brand names | Depakote, Depakote ER, Depakote Sprinkles |
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.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| divalproex sodium 125 mg capsule | Brand: Depakote Sprinkles | $1.97 per capsule |
| divalproex sodium 125 mg capsule, coated pellets | Generic | $0.1971 per capsule |
| divalproex sodium 125 mg capsule, delayed release | Generic | $0.1971 per capsule |
| divalproex sodium 125 mg tablet, delayed release | Generic | $0.0532 per tablet |
| divalproex sodium 125 mg tablet, delayed release | Brand: Depakote | $2.06 per tablet |
| divalproex sodium 250 mg tablet, delayed release | Generic | $0.0847 per tablet |
| divalproex sodium 250 mg tablet, delayed release | Brand: Depakote | $4.04 per tablet |
| divalproex sodium 250 mg tablet, extended release | Generic | $0.1386 per tablet |
| divalproex sodium 250 mg tablet, extended release | Brand: Depakote ER | $3.68 per tablet |
| divalproex sodium 250 mg tablet, film coated, extended release | Generic | $0.1386 per tablet |
| divalproex sodium 500 mg tablet, delayed release | Generic | $0.1561 per tablet |
| divalproex sodium 500 mg tablet, delayed release | Brand: Depakote | $7.46 per tablet |
| divalproex sodium 500 mg tablet, extended release | Generic | $0.1957 per tablet |
| divalproex sodium 500 mg tablet, extended release | Brand: Depakote ER | $6.49 per tablet |
| divalproex sodium 500 mg tablet, film coated, extended release | Generic | $0.1957 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.
- Remedyrepack Inc.20 products
- Bryant Ranch Prepack17 products
- American Health Packaging10 products
- A-S Medication Solutions9 products
- Aphena Pharma Solutions - Tennessee, LLC8 products
- NCS HealthCare of KY, LLC dba Vangard Labs8 products
- Coupler LLC8 products
- BluePoint Laboratories7 products
- Cardinal Health 107, LLC7 products
- AbbVie Inc.6 products
- Preferred Pharmaceuticals Inc.5 products
- Major Pharmaceuticals5 products
- Unichem Pharmaceuticals (USA), Inc.5 products
- Aurobindo Pharma Limited5 products
- Lupin Pharmaceuticals, Inc.5 products
- Dr. Reddy's Laboratories Limited3 products
- NorthStar Rx LLC3 products
- Rising Pharma Holdings, Inc.3 products
- Sun Pharmaceutical Industries, Inc.3 products
- Dr.Reddy's Laboratories Ltd.3 products
- Proficient Rx LP3 products
- PD-Rx Pharmaceuticals, Inc.3 products
- Bionpharma Inc.3 products
- Upsher-Smith Laboratories, LLC3 products
- Mylan Institutional Inc.2 products
- Amneal Pharmaceuticals LLC2 products
- Unit Dose Solutions, Inc.2 products
- Safecor Health LLC2 products
- AvPAK2 products
- Direct_Rx2 products
- Atlantic Biologicals Corp.2 products
- St. Mary's Medical Park Pharmacy2 products
- Camber Pharmaceuticals, Inc.2 products
- Mylan Pharmaceuticals Inc.2 products
- Zydus Lifesciences Limited1 product
- Alembic Pharmaceuticals Limited1 product
- DirectRx1 product
- Zydus Pharmaceuticals USA Inc.1 product
- Lifestar Pharma LLC1 product
- First Nation Group, LLC1 product
- Ajanta Pharma USA Inc.1 product
- Northwind Health Company, LLC1 product
- Alembic Pharmaceuticals Inc.1 product
- NuCare Pharmaceuticals, Inc.1 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 |
|---|---|---|---|
| NDA018723 DEPAKOTE | Abbvie | March 10, 1983 | 56, latest March 31, 2026 2026: Labeling · 2025: Labeling · 2025: Labeling |
| NDA019680 DEPAKOTE | Abbvie | September 12, 1989 | 44, latest March 31, 2026 2026: Labeling · 2025: Labeling · 2025: Labeling |
| NDA021168 DEPAKOTE ER | Abbvie | August 4, 2000 | 41, latest March 31, 2026 2026: Labeling · 2025: Labeling · 2025: Labeling |
Generic approvals (21)
- ANDA078182Upsher Smith Labs · July 29, 2008
- ANDA078597Sun Pharm Inds · July 29, 2008
- ANDA078755DR Reddys Labs Ltd · July 29, 2008
- ANDA078790Lupin · July 29, 2008
- ANDA078853Orbion Pharms · November 25, 2008
- ANDA078979DR Reddys Labs Ltd · January 23, 2009
- ANDA078919Zydus Pharms USA Inc · January 27, 2009
- ANDA077567Mylan · January 29, 2009
- ANDA078239Zydus Pharms USA Inc · February 27, 2009
- ANDA079163Unichem Labs Ltd · April 5, 2011
- ANDA090554Aurobindo Pharma Ltd · April 21, 2011
- ANDA090070Reddys · March 12, 2012
- ANDA090161DR Reddys Labs Ltd · March 15, 2012
- ANDA202419Aurobindo Pharma Ltd · June 2, 2014
- ANDA203730Amneal Pharms · May 29, 2015
- ANDA209286Lupin · October 18, 2019
- ANDA213181Ajanta Pharma Ltd · February 28, 2020
- ANDA214643Unichem · February 25, 2022
- ANDA215527Annora Pharma · September 26, 2023
- ANDA218793Alembic · December 19, 2024
- ANDA217358Mankind Pharma · August 12, 2025
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.
-
June 26, 2026 · Class II · Ongoing · D-0742-2026
Presence of Foreign Tablets/Capsules
Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, Made in India, NDC 69452-435-30. — Bionpharma Inc.
-
December 26, 2023 · Class II · Terminated · D-0426-2024
Failed dissolution specifications
Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 651 — Amneal Pharmaceuticals of New York, LLC
-
July 27, 2022 · Class II · Terminated · D-1362-2022
Failed dissolution specifications.
Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, India, Distributed by: Amneal Pharmaceuticals, Bridgewater, NJ, NDC 65162-755-10 — Amneal Pharmaceuticals of New York, LLC
-
June 27, 2022 · Class II · Terminated · D-1291-2022
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda High — SUN PHARMACEUTICAL INDUSTRIES INC
-
April 24, 2019 · Class II · Terminated · D-1583-2019
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 — MAJOR PHARMACEUTICALS
-
January 31, 2019 · Class II · Terminated · D-0507-2019
Failed Dissolution Specifications: Out of specification results observed for high dissolution.
Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India NDC 55111-533-01 — Dr. Reddy's Laboratories, Inc.
-
December 19, 2017 · Class II · Terminated · D-0228-2018
Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories Ltd. Ind. Area, Meerut Road, Ghaziabad-201 003, India. Marketed By: Unichem Pharmaceuticals (USA), I — Unichem Pharmaceuticals Usa Inc
-
May 22, 2015 · Class II · Terminated · D-1136-2015
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited Bachupally 500 090 India --- NDC 55111-534-01 — Dr. Reddy's Laboratories, Inc.
-
May 22, 2015 · Class II · Terminated · D-1135-2015
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited, Bachupally 500 — Dr. Reddy's Laboratories, 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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Depakote, AbbVie Inc., effective March 31, 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 →