Medicine
Sodium chloride 4500 mg/500 mL injection
Sodium chloride 4500 mg/500 mL injection is a generic prescription medicine for intravenous use, made by 11 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
It is recommended the product be stored at room temperature (25° C/ 77° F)…
Key facts
- Active ingredient (INN)
- Sodium chloride
- Brand
- Sold under the generic name
- Strength
- 4500 mg/500 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 500 mL, 20 bags of 500 mL, 24 containers of 500 mL and 19 more
- Manufacturers
- Fresenius KabiBaxter HealthcareHealthFirstB. Braun MedicalICU MedicalLaboratorios GrifolsBecton DickinsonCodanNephron PharmaceuticalsNextgen Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- It is recommended the product be stored at room temperature (25° C/ 77° F), brief exposure up to 40° C/ 104°F does not adversely affect the product.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A12CA01 Sodium chloride
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 9 December 1970
- Identifiers
- RxCUI 1807631, 1807632, 1807633 +6DailyMed set ID a4edf2d5-a9ff-30d4-e053-2995a90a5650, eb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf, 28f79c75-82d2-4912-81fc-a723b5ccf4c1 +16NDC 0487-4301, 76297-001, 79672-613 +16Application ANDA211968, ANDA207956, NDA016366 +3
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 |
|---|---|---|---|
| 500 mL in 1 bag | 63323-623-75 | Fresenius Kabi | 19 September 2017 |
| 20 bag in 1 case / 500 mL in 1 bag | 63323-632-75 | Fresenius Kabi | 19 September 2017 |
| 20 bag in 1 case / 500 mL in 1 bag | 65219-224-50 | Fresenius Kabi | 17 November 2021 |
| 20 bag in 1 case / 500 mL in 1 bag | 65219-432-85 | Fresenius Kabi | 19 September 2017 |
| 20 bag in 1 case / 500 mL in 1 bag | 65219-472-20 | Fresenius Kabi | 19 September 2017 |
| 24 container in 1 case / 500 mL in 1 container | 0264-5802-10 | B. Braun Medical | 26 January 2022 |
| 24 container in 1 case / 500 mL in 1 container | 0264-7800-10 | B. Braun Medical | 9 March 1988 |
| 500 mL in 1 bag | 0338-0049-03 | Baxter Healthcare | 9 December 1970 |
| 500 mL in 1 bag | 0338-9543-03 | Baxter Healthcare | 9 December 1970 |
| 500 mL in 1 bag | 0338-9543-04 | Baxter Healthcare | 9 December 1970 |
| 500 mL in 1 bag | 17271-701-06 | Becton Dickinson | 19 September 2017 |
| 20 bag in 1 carton / 500 mL in 1 bag | 81826-001-31 | Codan | 5 August 2021 |
| 24 pouch in 1 case / 1 bag in 1 pouch / 500 mL in 1 bag | 0990-7983-03 | ICU Medical | 31 December 2019 |
| 18 pouch in 1 case / 1 bag in 1 pouch / 500 mL in 1 bag | 0990-7983-55 | ICU Medical | 31 December 2019 |
| 20 bag in 1 carton / 500 mL in 1 bag | 76297-001-01 | Laboratorios Grifols | 25 May 2017 |
| 24 bag in 1 carton / 500 mL in 1 bag | 76297-001-81 | Laboratorios Grifols | 6 August 2022 |
| 18 bag in 1 case / 500 mL in 1 bag | 0487-4301-50 | Nephron Pharmaceuticals | 4 June 2020 |
| 20 bag in 1 carton / 500 mL in 1 bag | 79672-613-40 | Nextgen Pharmaceuticals | 15 February 2021 |
| 20 bag in 1 carton / 500 mL in 1 bag | 70512-841-51 | SOLA Pharmaceuticals | 20 December 2023 |
| 500 mL in 1 bag | 51662-1522-1 | HealthFirst | 4 August 2020 |
| 500 mL in 1 bag | 51662-1577-1 | HealthFirst | 17 July 2021 |
| 500 mL in 1 bag | 51662-1609-1 | HealthFirst | 31 July 2022 |
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 12 August 1970 | 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 chloride
Clinical summary
Sodium chloride is an osmotic laxative indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution. MedsAcross supplies Sodium chloride 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 chlorideFor 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 Chloride prescribing information (B. Braun Medical) · U.S. National Library of Medicine, DailyMed
Need Sodium chloride 4500 mg/500 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.