Medicine
Sodium benzoate and Sodium phenylacetate 2000 mg/2000 mg per 20 mL injection
Sodium benzoate and Sodium phenylacetate 2000 mg/2000 mg per 20 mL injection is a generic prescription medicine for intravenous use, made by 4 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°C to 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to…
Key facts
- Active ingredient (INN)
- Sodium benzoate and Sodium phenylacetate
- Brand
- Sold under the generic name
- Strength
- 2000 mg/2000 mg per 20 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 20 mL and 1 more
- Manufacturers
- Zydus LifesciencesIndiaFosun PharmaMAIA PharmaceuticalsNavinta
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
- 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
- 1 July 2021
- Identifiers
- RxCUI 2560228DailyMed set ID cee1e9a2-bbe5-2419-e053-2a95a90ac3ef, d20768fe-4516-483a-a082-ff1df9ad1d99, ab40b62b-9f8d-4394-92d5-09d9f1941eaa +1NDC 72266-236, 68475-513, 70511-102 +1Application NDA215025, ANDA217526
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 |
|---|---|---|---|
| 1 vial in 1 carton / 20 mL in 1 vial | 70710-1926-1 | Zydus LifesciencesIndia | 19 September 2023 |
| 1 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose | 72266-236-01 | Fosun Pharma | 14 November 2021 |
| 1 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose | 70511-102-20 | Maia Pharmaceuticals | 1 July 2021 |
| 1 vial in 1 carton / 20 mL in 1 vial | 68475-513-01 | Navinta | 6 December 2025 |
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 23 December 1987 | 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 Sodium benzoate and Sodium phenylacetate
Clinical summary
Sodium benzoate and Sodium phenylacetate is a fixed-dose combination medicine. It is available as injection for intravenous use. MedsAcross supplies Sodium benzoate and Sodium phenylacetate 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 Sodium benzoate and Sodium phenylacetateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Sodium Phenylacetate and Sodium Benzoate prescribing information (Fosun Pharma) · U.S. National Library of Medicine, DailyMed
Need Sodium benzoate and Sodium phenylacetate 2000 mg/2000 mg per 20 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.