Medicine
Sodium benzoate and Sodium phenylacetate 5000 mg/5000 mg per 50 mL injection
Sodium benzoate and Sodium phenylacetate 5000 mg/5000 mg per 50 mL injection is a generic prescription medicine for intravenous use, made by 5 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 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
Key facts
- Active ingredient (INN)
- Sodium benzoate and Sodium phenylacetate
- Brand
- Sold under the generic name
- Strength
- 5000 mg/5000 mg per 50 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 50 mL and 3 more
- Manufacturers
- Zydus LifesciencesIndiaOmnivium PharmaceuticalsAilex PharmaceuticalsMAIA PharmaceuticalsNavinta
- Origin register
- US FDA, United States
- Storage
- Store at 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
- 24 February 2016
- Identifiers
- RxCUI 984118DailyMed set ID fbc7bfe3-6faa-45a3-befb-9ad7963c0571, 204e84a7-5440-4537-9e40-06eb56c415e9, 8fafc39b-69db-40f3-8a09-ee859e8cef19 +3NDC 68475-001, 68382-396, 81665-204 +3Application ANDA205880, ANDA207096, ANDA208521
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 / 50 mL in 1 vial | 68382-396-01 | Zydus LifesciencesIndia | 8 February 2021 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 81665-203-01 | Omnivium Pharmaceuticals | 25 February 2025 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 81665-204-01 | Omnivium Pharmaceuticals | 15 May 2025 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 70556-100-50 | Ailex Pharmaceuticals | 26 February 2016 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 70511-101-50 | Maia Pharmaceuticals | 22 May 2017 |
| 1 vial in 1 carton / 50 mL in 1 vial | 68475-001-50 | Navinta | 4 March 2021 |
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 5000 mg/5000 mg per 50 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.