Medicine
Sodium chloride 4.5 g/1000 mL injection
Sodium chloride 4.5 g/1000 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
0.45% Sodium Chloride Injection, USP is supplied in single-dose flexible…
Key facts
- Active ingredient (INN)
- Sodium chloride
- Brand
- Sold under the generic name
- Strength
- 4.5 g/1000 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 12 containers of 1000 mL, 1000 mL, 10 bags of 1000 mL and 3 more
- Manufacturers
- B. Braun MedicalBaxter HealthcareBecton DickinsonFresenius KabiICU Medical
- Origin register
- US FDA, United States
- Storage
- 0.45% Sodium Chloride Injection, USP is supplied in single-dose flexible plastic containers as follows: Product Code Unit of Sale Strength Each 626050 63323-626-50 Package of 60 0.225 grams per 50 mL (4.5 mg per mL) 63323-626-01 50 mL in a 100 mL free flex ® bag 626100 63323-626-00 Package of 50 0.45 grams per 100 mL (4.5 mg per mL) 63323-626-02 100 mL in a 100 mL free flex ® bag 626250…
- 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
- 2 February 1979
- Identifiers
- RxCUI 1807548, 1807549, 1807550 +7DailyMed set ID 83994d0c-8484-4505-abb5-8a384ed12288, 5f372b75-d7a4-471e-8ac6-290040fc84b0, e44c41ae-c9c8-4dd8-ba6c-cebb585378aa +3NDC 63323-626, 0990-7985, 0264-5804 +3Application ANDA208122, NDA018090, NDA019635 +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 |
|---|---|---|---|
| 12 container in 1 case / 1000 mL in 1 container | 0264-5804-00 | B. Braun Medical | 26 January 2022 |
| 12 container in 1 case / 1000 mL in 1 container | 0264-7802-00 | B. Braun Medical | 9 March 1988 |
| 1000 mL in 1 bag | 0338-0043-04 | Baxter Healthcare | 2 February 1979 |
| 10 bag in 1 case / 1000 mL in 1 bag | 17271-700-07 | Becton Dickinson | 23 July 2018 |
| 10 bag in 1 case / 1000 mL in 1 bag | 63323-626-10 | Fresenius Kabi | 23 July 2018 |
| 12 pouch in 1 case / 1 bag in 1 pouch / 1000 mL in 1 bag | 0990-7985-09 | ICU Medical | 1 November 2019 |
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 4.5 g/1000 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.