Medicine
Valproic acid 250 mg/5 mL oral solution
Valproic acid 250 mg/5 mL oral solution is a generic prescription medicine for oral use, made by 12 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 at 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Valproic acid
- Brand
- Sold under the generic name
- Strength
- 250 mg/5 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 473 mL, 10 trays, 4 trays and 27 more
- Manufacturers
- RemedyrepackPAI PharmaXttrium LaboratoriesAmerican Health PackagingChartwell RXMajor PharmaceuticalsChartwell Governmental & Specialty RXKesin PharmaANI PharmaceuticalsBryant Ranch Prepack
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°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
- 1 July 1986
- Identifiers
- RxCUI 1099687DailyMed set ID 5d19f389-7180-4e01-845f-519b7ea60ba0, 65c1589e-c591-4b79-b75e-884c0d609ae8, a33f7657-ad0f-43e9-ba48-024746e6d08e +10NDC 68999-874, 70518-3805, 0904-7621 +16Application ANDA075782, ANDA075379, ANDA070868 +2
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 473 mL in 1 bottle | 0121-0675-85 | PAI Pharma | 11 August 2021 |
| 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 10 mL in 1 cup, unit-dose | 0121-1350-00 | PAI Pharma | 11 April 2005 |
| 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 0121-4675-00 | PAI Pharma | 11 April 2005 |
| 4 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 0121-4675-40 | PAI Pharma | 11 April 2005 |
| 2 tray in 1 box / 10 cup in 1 tray / 5 mL in 1 cup | 68999-196-24 | Chartwell Governmental & Specialty RX | 14 November 2025 |
| 2 tray in 1 box / 10 cup in 1 tray / 10 mL in 1 cup | 68999-874-24 | Chartwell Governmental & Specialty RX | 14 November 2025 |
| 2 tray in 1 box / 10 cup in 1 tray / 5 mL in 1 cup | 62135-196-24 | Chartwell RX | 28 May 2024 |
| 473 mL in 1 bottle | 62135-196-47 | Chartwell RX | 15 August 2022 |
| 2 tray in 1 box / 10 cup in 1 tray / 10 mL in 1 cup | 62135-874-24 | Chartwell RX | 28 May 2024 |
| 473 mL in 1 bottle | 62559-266-16 | ANI Pharmaceuticals | 2 January 2024 |
| 12 bottle in 1 case / 473 mL in 1 bottle | 70752-202-12 | Quagen Pharmaceuticals | 15 April 2024 |
| 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 10 mL in 1 cup, unit-dose | 0116-4021-11 | Xttrium Laboratories | 29 July 2025 |
| 473 mL in 1 bottle, plastic | 0116-4021-16 | Xttrium Laboratories | 29 July 2025 |
| 4 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 0116-4021-40 | Xttrium Laboratories | 29 July 2025 |
| 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 0116-4021-41 | Xttrium Laboratories | 29 July 2025 |
| 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 60687-942-17 | American Health Packaging | 4 August 2026 |
| 4 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 60687-942-77 | American Health Packaging | 4 August 2026 |
| 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 10 mL in 1 cup, unit-dose | 60687-953-56 | American Health Packaging | 4 August 2026 |
| 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 0904-7620-70 | Major Pharmaceuticals | 3 August 2026 |
| 4 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 0904-7620-94 | Major Pharmaceuticals | 3 August 2026 |
| 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 10 mL in 1 cup, unit-dose | 0904-7621-72 | Major Pharmaceuticals | 3 August 2026 |
| 10 cup, unit-dose in 1 box / 5 mL in 1 cup, unit-dose | 70518-3805-0 | Remedyrepack | 25 July 2023 |
| 10 cup, unit-dose in 1 box / 10 mL in 1 cup, unit-dose | 70518-3805-2 | Remedyrepack | 13 March 2024 |
| 10 cup in 1 box / 20 mL in 1 cup | 70518-4298-0 | Remedyrepack | 27 February 2025 |
| 10 cup in 1 box / 10 mL in 1 cup | 70518-4298-2 | Remedyrepack | 27 February 2025 |
| 10 cup in 1 box / 5 mL in 1 cup | 70518-4298-4 | Remedyrepack | 27 February 2025 |
| 473 mL in 1 bottle | 71335-2250-1 | Bryant Ranch Prepack | 11 August 2021 |
| 100 cup, unit-dose in 1 case / 5 mL in 1 cup, unit-dose | 81033-266-50 | Kesin Pharma | 1 August 2025 |
| 100 cup, unit-dose in 1 case / 10 mL in 1 cup, unit-dose | 81033-266-52 | Kesin Pharma | 1 August 2025 |
| 473 mL in 1 bottle | 72603-253-01 | NorthStar Rx | 10 June 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 28 February 1978 | 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
Other strengths and forms of Valproic acid
Clinical summary
Valproic acid is an anti-epileptic agent indicated for monotherapy and adjunctive therapy of complex partial seizures, sole and adjunctive therapy of simple and complex absence seizures, among other approved uses. MedsAcross supplies Valproic acid 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 Valproic acidFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- VALPROIC ACID prescribing information (PAI Pharma) · U.S. National Library of Medicine, DailyMed
Need Valproic acid 250 mg/5 mL oral solution for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.