Medicine
Sodium acetate 3280 mg/20 mL injection
Sodium acetate 3280 mg/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° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Sodium acetate
- Brand
- Sold under the generic name
- Strength
- 3280 mg/20 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 25 vials of 20 mL, 25 bottles of 20 mL, 1 vial of 20 mL and 2 more
- Manufacturers
- HospiraAmneal PharmaceuticalsHikma PharmaceuticalsMilla Pharmaceuticals
- 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
- B05XA08 Sodium acetate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 31 March 2005
- Identifiers
- RxCUI 1859490DailyMed set ID 8a338072-6f1e-460c-b9ec-59cef4f3f597, ce9a7469-c4ba-4f60-8f7a-47ef0974316e, 0c0b11da-d7fc-4b4c-b0ef-d97af8e88abf +2NDC 0641-6261, 0409-7299, 80830-2435 +1Application ANDA216920, NDA018893, ANDA218469 +1
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 |
|---|---|---|---|
| 25 vial, single-dose in 1 tray / 20 mL in 1 vial, single-dose | 0409-7299-25 | Hospira | 5 March 2014 |
| 25 vial, single-dose in 1 tray / 20 mL in 1 vial, single-dose | 0409-7299-73 | Hospira | 31 March 2005 |
| 25 bottle, plastic in 1 carton / 20 mL in 1 bottle, plastic | 80830-2435-2 | Amneal Pharmaceuticals | 3 March 2026 |
| 1 vial in 1 carton / 20 mL in 1 vial | 0641-6261-01 | Hikma Pharmaceuticals | 20 May 2024 |
| 10 vial, single-dose in 1 case / 20 mL in 1 vial, single-dose | 71357-002-10 | Milla Pharmaceuticals | 17 January 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 4 May 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
Other strengths and forms of Sodium acetate
Clinical summary
Sodium acetate is an osmotic laxative indicated as a source of sodium, for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. MedsAcross supplies Sodium acetate 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 acetateFor 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 Acetate prescribing information (Hospira) · U.S. National Library of Medicine, DailyMed
Need Sodium acetate 3280 mg/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.