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Medicine

Sodium chloride 450 mg/50 mL injection

Sodium chloride · Intravenous
Available on requestPrescription onlyUS FDAGeneric name

Sodium chloride 450 mg/50 mL injection is a generic prescription medicine for intravenous use, made by 10 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Protect from freezing. Store at 20 to 25°C (68 to 77°F).

Key facts

Active ingredient (INN)
Sodium chloride
Brand
Sold under the generic name
Strength
450 mg/50 mL
Dosage form
Injection
Route
Intravenous
Packs
4 bags of 50 mL, 16 bags of 50 mL, 1 bag of 50 mL and 21 more
Manufacturers
Baxter HealthcareFresenius KabiBecton DickinsonICU MedicalLaboratorios GrifolsB. Braun MedicalCodanNephron PharmaceuticalsNextgen PharmaceuticalsSOLA Pharmaceuticals
Origin register
US FDA, United States
Storage
Protect from freezing. 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
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 5f372b75-d7a4-471e-8ac6-290040fc84b0, d98bf9f7-30ec-4927-a577-cabad192cb18, 958d35f0-6834-43be-a700-fa58f38b4c19 +15NDC 0990-7984, 65219-218, 0338-9659 +17Application NDA016366, ANDA207310, NDA016677 +4

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.

PackCodeLabelerMarketed since
4 bag in 1 package / 50 mL in 1 bag0338-0049-11Baxter Healthcare9 December 1970
16 bag in 1 package / 50 mL in 1 bag0338-0049-31Baxter Healthcare9 December 1970
1 bag in 1 package / 50 mL in 1 bag0338-0049-41Baxter Healthcare9 December 1970
80 bag in 1 carton / 50 mL in 1 bag0338-0182-04Baxter Healthcare7 December 2022
80 bag in 1 carton / 50 mL in 1 bag0338-0192-04Baxter Healthcare7 December 2022
50 mL in 1 bag0338-0553-11Baxter Healthcare7 December 1992
50 mL in 1 bag0338-9151-30Baxter Healthcare19 February 2021
50 mL in 1 bag0338-9657-75Baxter Healthcare9 August 2024
50 mL in 1 bag0338-9659-75Baxter Healthcare9 August 2024
40 bag in 1 carton / 50 mL in 1 bag0338-9660-40Baxter Healthcare30 July 2025
50 mL in 1 bag63323-623-53Fresenius Kabi19 September 2017
60 bag in 1 case / 50 mL in 1 bag65219-218-50Fresenius Kabi17 November 2021
60 bag in 1 case / 50 mL in 1 bag65219-466-60Fresenius Kabi19 September 2017
50 mL in 1 bag17271-701-02Becton Dickinson19 September 2017
60 bag in 1 case / 50 mL in 1 bag17271-771-02Becton Dickinson17 November 2021
84 container in 1 case / 50 mL in 1 container0264-1800-31B. Braun Medical8 February 1978
115 bag in 1 carton / 50 mL in 1 bag81826-001-01Codan5 August 2021
48 pouch in 1 case / 1 bag in 1 pouch / 50 mL in 1 bag0990-7984-13ICU Medical1 May 2019
20 pouch in 1 case / 4 bag in 1 pouch / 50 mL in 1 bag0990-7984-36ICU Medical1 May 2019
115 bag in 1 carton / 50 mL in 1 bag76297-001-11Laboratorios Grifols1 December 2018
90 bag in 1 carton / 50 mL in 1 bag76297-001-51Laboratorios Grifols6 August 2022
64 bag in 1 case / 50 mL in 1 bag0487-4301-05Nephron Pharmaceuticals4 June 2020
115 bag in 1 carton / 50 mL in 1 bag79672-613-10Nextgen Pharmaceuticals15 February 2021
115 bag in 1 carton / 50 mL in 1 bag70512-841-06SOLA Pharmaceuticals20 December 2023
25 vial, single-dose in 1 tray / 50 mL in 1 vial, single-dose0409-4888-50—28 February 2005
50 mL in 1 vial, plastic51662-1359-1—18 July 2019
1 vial, single-dose in 1 bag / 50 mL in 1 vial, single-dose0404-9954-50—12 January 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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 12 August 1970Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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

Alternatives

Other makers and brands of Sodium chloride 450 mg/50 mL injection.

Compare 1

Other strengths and forms of Sodium chloride

injection112.5 mg/125 mL injection1125 mg/250 mL injection1350 mg/150 mL injection15 g/500 mL injection18 g/2000 mL injection18 mg/2 mL injection180 mg/20 mL injection2.5 mEq/mL injection225 mg/25 mL injection225 mg/50 mL injection2250 mg/250 mL injection2250 mg/500 mL injection23400 mg/100 mL injection25 g/500 mL injection27 g/3000 mL injection270 mg/30 mL injection4 mEq/mL injection4.5 g/1000 mL injection45 mg/5 mL injection450 mg/100 mL injection4500 mg/500 mL injection5.84 g/40 mL injection9 g/1000 mL injectionSee all 39 presentations

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 chloride

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

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