Medicine
Divalproex 250 mg extended-release tablet
Divalproex 250 mg extended-release tablet is a generic prescription medicine for oral use, made by 20 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store tablets at 20° to 25°C (68° to 77°F), excursions permitted between 15°…
Key facts
- Active ingredient (INN)
- Divalproex
- Brand
- Sold under the generic name
- Strength
- 250 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 10 blister pack and 55 more
- Manufacturers
- Aurobindo PharmaIndiaDr. Reddy's LaboratoriesIndiaCamber PharmaceuticalsIndiaLupinIndiaUnichem LaboratoriesIndiaAphena Pharma Solutions - TennesseeRemedyrepackAmneal PharmaceuticalsMylan PharmaceuticalsMylan Institutional20 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store tablets at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N03AG01 Valproic acid
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 January 2009
- Identifiers
- RxCUI 1099563, 1099569DailyMed set ID e8cc336b-5191-7f8b-e053-2a95a90a6acb, a8ba3986-1ded-44a8-8d10-d0f252a07794, 74a9f020-f7a1-44e2-a452-f0e37bd3e077 +27NDC 50268-259, 68084-310, 70518-1138 +27Application ANDA203730, ANDA078239, ANDA090161 +5
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
A sample of 40 packs from 20 labelers. The register lists 58 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, film coated, extended release in 1 bottle | 65862-594-01 | Aurobindo PharmaIndia | 2 June 2014 |
| 500 tablet, film coated, extended release in 1 bottle | 65862-594-05 | Aurobindo PharmaIndia | 2 June 2014 |
| 10 blister pack in 1 carton / 10 tablet, film coated, extended release in 1 blister pack | 65862-594-10 | Aurobindo PharmaIndia | 2 June 2014 |
| 60 tablet, film coated, extended release in 1 bottle | 65862-594-60 | Aurobindo PharmaIndia | 2 June 2014 |
| 1000 tablet, film coated, extended release in 1 bottle | 65862-594-99 | Aurobindo PharmaIndia | 2 June 2014 |
| 100 tablet, film coated, extended release in 1 bottle | 31722-021-01 | Camber PharmaceuticalsIndia | 26 September 2023 |
| 500 tablet, film coated, extended release in 1 bottle | 31722-021-05 | Camber PharmaceuticalsIndia | 26 September 2023 |
| 100 tablet, film coated, extended release in 1 bottle | 55111-533-01 | Dr. Reddy's LaboratoriesIndia | 11 August 2013 |
| 500 tablet, film coated, extended release in 1 bottle | 55111-533-05 | Dr. Reddy's LaboratoriesIndia | 11 August 2013 |
| 30 tablet, film coated, extended release in 1 bottle | 55111-533-30 | Dr. Reddy's LaboratoriesIndia | 11 August 2013 |
| 60 tablet, film coated, extended release in 1 bottle | 55111-533-60 | Dr. Reddy's LaboratoriesIndia | 11 August 2013 |
| 10 blister pack in 1 carton / 10 tablet, film coated, extended release in 1 blister pack | 55111-533-78 | Dr. Reddy's LaboratoriesIndia | 11 August 2013 |
| 100 tablet, extended release in 1 bottle | 68180-260-01 | LupinIndia | 18 September 2020 |
| 500 tablet, extended release in 1 bottle | 68180-260-02 | LupinIndia | 18 September 2020 |
| 100 tablet, film coated, extended release in 1 bottle | 29300-380-01 | Unichem LaboratoriesIndia | 15 July 2022 |
| 500 tablet, film coated, extended release in 1 bottle | 29300-380-05 | Unichem LaboratoriesIndia | 15 July 2022 |
| 100 tablet, extended release in 1 bottle | 65162-755-10 | Amneal Pharmaceuticals | 1 June 2015 |
| 500 tablet, extended release in 1 bottle | 65162-755-50 | Amneal Pharmaceuticals | 1 June 2015 |
| 80 blister pack in 1 carton / 1 tablet, film coated, extended release in 1 blister pack | 51079-766-08 | Mylan Institutional | 3 February 2009 |
| 100 tablet, film coated, extended release in 1 bottle, plastic | 0378-0472-01 | Mylan Pharmaceuticals | 29 January 2009 |
| 500 tablet, film coated, extended release in 1 bottle, plastic | 0378-0472-05 | Mylan Pharmaceuticals | 29 January 2009 |
| 30 tablet, extended release in 1 blister pack | 70518-1138-0 | Remedyrepack | 25 April 2018 |
| 100 pouch in 1 box / 1 tablet, extended release in 1 pouch | 70518-1556-1 | Remedyrepack | 10 July 2019 |
| 30 tablet, extended release in 1 blister pack | 70518-1556-5 | Remedyrepack | 29 June 2024 |
| 100 pouch in 1 box / 1 tablet, film coated, extended release in 1 pouch | 70518-1781-1 | Remedyrepack | 3 August 2020 |
| 30 tablet, extended release in 1 blister pack | 70518-3183-0 | Remedyrepack | 6 August 2021 |
| 100 pouch in 1 box / 1 tablet, extended release in 1 pouch | 70518-3183-1 | Remedyrepack | 30 July 2023 |
| 30 tablet, film coated, extended release in 1 blister pack | 70518-4557-0 | Remedyrepack | 27 January 2026 |
| 30 tablet, film coated, extended release in 1 bottle, plastic | 71610-030-30 | Aphena Pharma Solutions - Tennessee | 12 November 2018 |
| 90 tablet, film coated, extended release in 1 bottle, plastic | 71610-030-60 | Aphena Pharma Solutions - Tennessee | 18 January 2018 |
| 150 tablet, film coated, extended release in 1 bottle, plastic | 71610-030-75 | Aphena Pharma Solutions - Tennessee | 9 February 2018 |
| 180 tablet, film coated, extended release in 1 bottle, plastic | 71610-030-80 | Aphena Pharma Solutions - Tennessee | 10 July 2019 |
| 270 tablet, film coated, extended release in 1 bottle, plastic | 71610-030-92 | Aphena Pharma Solutions - Tennessee | 10 July 2019 |
| 90 tablet, film coated, extended release in 1 bottle | 71610-157-60 | Aphena Pharma Solutions - Tennessee | 20 September 2018 |
| 150 tablet, film coated, extended release in 1 bottle | 71610-157-75 | Aphena Pharma Solutions - Tennessee | 20 September 2018 |
| 30 tablet, film coated, extended release in 1 bottle | 71610-289-30 | Aphena Pharma Solutions - Tennessee | 5 June 2019 |
| 90 tablet, film coated, extended release in 1 bottle | 71610-289-60 | Aphena Pharma Solutions - Tennessee | 5 June 2019 |
| 150 tablet, film coated, extended release in 1 bottle | 71610-289-75 | Aphena Pharma Solutions - Tennessee | 5 June 2019 |
| 180 tablet, film coated, extended release in 1 bottle | 71610-289-80 | Aphena Pharma Solutions - Tennessee | 3 September 2024 |
| 270 tablet, film coated, extended release in 1 bottle | 71610-289-92 | Aphena Pharma Solutions - Tennessee | 3 September 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 10 March 1983 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Divalproex 250 mg extended-release tablet.
Other strengths and forms of Divalproex
Clinical summary
Divalproex is an anti-epileptic agent indicated for treatment of manic episodes associated with bipolar disorder, among other approved uses. It is available as delayed-release tablets, extended-release tablets and capsules for oral use. MedsAcross supplies Divalproex for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about DivalproexFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Depakote prescribing information (AbbVie) · U.S. National Library of Medicine, DailyMed
Need Divalproex 250 mg extended-release tablet for your hospital or patient?
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