Medicine
Valproate 500 mg/5 mL injection
Valproate 500 mg/5 mL injection is a generic prescription medicine for intravenous use, made by 3 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 vials at 20º to 25ºC (68º to 77ºF) with excursions between 15º and 30ºC…
Key facts
- Active ingredient (INN)
- Valproate
- Brand
- Sold under the generic name
- Strength
- 500 mg/5 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 10 vials of 5 mL and 2 more
- Manufacturers
- Fresenius KabiHikma PharmaceuticalsSagent Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store vials at 20º to 25ºC (68º to 77ºF) with excursions between 15º and 30ºC (59º and 86ºF).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 18 August 2003
- Identifiers
- RxCUI 1099648DailyMed set ID bcf57b31-4811-4104-82b3-46fb91a53ee0, 7a687b2f-246d-4736-a20c-92421c263268, 3dfb6da1-f66a-4618-9f74-d2d6c16c0b58 +2NDC 0143-9785, 0143-9637, 63323-494 +1Application ANDA078523, ANDA076539, ANDA076295
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 |
|---|---|---|---|
| 10 vial, single-dose in 1 tray / 5 mL in 1 vial, single-dose | 63323-494-05 | Fresenius Kabi | 18 August 2003 |
| 10 vial, single-dose in 1 tray / 5 mL in 1 vial, single-dose | 63323-494-16 | Fresenius Kabi | 18 August 2003 |
| 10 vial, single-dose in 1 tray / 5 mL in 1 vial, single-dose | 0143-9637-10 | Hikma Pharmaceuticals | 15 April 2013 |
| 10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 0143-9785-10 | Hikma Pharmaceuticals | 17 February 2010 |
| 10 vial in 1 carton / 5 mL in 1 vial | 25021-797-05 | Sagent Pharmaceuticals | 1 December 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 30 December 1996 | 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
Clinical summary
Valproate is an anti-epileptic agent indicated as an intravenous alternative in patients in whom oral administration of valproate products is temporarily not feasible in conditions, among other approved uses. It is available as injection for intravenous use. MedsAcross supplies Valproate 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 ValproateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Valproate Sodium prescribing information (Sagent Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Valproate 500 mg/5 mL injection 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.