Quick answers
- What is Sodium chloride used for?
- The FDA-approved label (Bacteriostatic Sodium Chloride, Hospira, Inc., April 3, 2026) says: “This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sodium chloride have a boxed warning?
- Yes. The FDA label for Bacteriostatic Sodium Chloride has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Sodium chloride?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated December 3, 2025). Ask your pharmacist about alternatives.
- Has Sodium chloride been recalled?
- FDA enforcement reports list 72 recalls of products of this medicine; the newest started August 19, 2026 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Sodium chloride?
- 25 companies list prescription products of Sodium chloride in the FDA NDC Directory, including Fresenius Kabi USA, LLC, Baxter Healthcare Corporation and B. Braun Medical Inc..
What Sodium chloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
— FDA label: Bacteriostatic Sodium Chloride, Hospira, Inc., effective April 3, 2026. Read the full label on DailyMed →
The FDA has 81 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
5 of 81 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection · Injection, solution, concentrate · Irrigant · Solution |
|---|---|
| Route | Intravenous · Intramuscular · Subcutaneous · Irrigation · Intravascular · Extracorporeal |
| Prescription products | 117 in the FDA NDC Directory |
| Brand names | Bacteriostatic Sodium Chloride |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| sodium chloride 9 g/1000 mL injection, solution | Generic | $0.0021 per mL |
| sodium chloride 9 mg/mL injection | Generic | $0.0915 per mL |
| sodium chloride 9 mg/mL injection, solution | Generic | $0.0699–$0.0915 per mL 3 packages, lowest to highest |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Fresenius Kabi USA, LLC29 products
- Baxter Healthcare Corporation26 products
- B. Braun Medical Inc.11 products
- HF Acquisition Co LLC, DBA HealthFirst11 products
- ICU Medical Inc.6 products
- Hospira, Inc.5 products
- Becton Dickinson and Company5 products
- Henry Schein, Inc.4 products
- ProPharma Distribution3 products
- Medical Purchasing Solutions, LLC2 products
- Hikma Pharmaceuticals USA Inc.2 products
- Spectra Medical Deviecs, LLC2 products
- Cardinal Health 107, LLC2 products
- Fresenius Medical Care de Mexico, S.A. de C.V.1 product
- Laboratorios Grifols SA1 product
- Asclemed USA, Inc.1 product
- Nephron Pharmaceuticals Corporation1 product
- Baxter Healthcare Company1 product
- Liebel-Flarsheim Company LLC1 product
- Fresenius Medical Care Renal Therapies Group, LLC1 product
- Sportpharm LLC1 product
- Nextgen Pharmaceuticals LLC1 product
- Codan US Corporation1 product
- SOLA Pharmaceuticals, LLC1 product
- Medefil, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA016366 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Otsuka Icu Medcl | February 24, 1972 | 142, latest September 21, 2017 2017: Labeling · 2016: Manufacturing (CMC) · 2014: Manufacturing (CMC) |
| NDA016677 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Baxter Hlthcare | December 9, 1970 | 103, latest July 24, 2024 2024: Labeling · 2019: Labeling · 2018: Manufacturing (CMC) |
| NDA016733 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | B Braun | August 12, 1970 | 48, latest March 9, 2026 2026: Labeling · 2015: Manufacturing (CMC) · 2014: Manufacturing (CMC) |
| NDA017427 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Baxter Hlthcare | December 31, 1974 | 57, latest February 24, 2016 2016: Manufacturing (CMC) · 2015: Manufacturing (CMC) · 2011: Manufacturing (CMC) |
| NDA017464 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | B Braun | February 8, 1978 | 38, latest October 16, 2006 2006: Labeling · 2004: Labeling · 2003: Labeling |
| NDA017867 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Baxter Hlthcare | May 30, 1980 | 42, latest August 29, 2001 2001: Manufacturing (CMC) · 2000: Manufacturing (CMC) · 1999: Labeling |
| NDA018016 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | Baxter Hlthcare | February 2, 1979 | 48, latest July 24, 2024 2024: Labeling · 2019: Labeling · 2014: Labeling |
| NDA018090 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | Otsuka Icu Medcl | April 4, 1979 | 75, latest September 21, 2017 2017: Labeling · 2017: Labeling · 2014: Manufacturing (CMC) |
| NDA018314 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Otsuka Icu Medcl | February 22, 1980 | 46, latest February 7, 2011 2011: Labeling · 2004: Labeling · 1997: Manufacturing (CMC) |
| NDA018800 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Hospira | October 29, 1982 | 14, latest January 6, 2017 2017: Manufacturing (CMC) · 2014: Manufacturing (CMC) · 2014: Manufacturing (CMC) |
| NDA018803 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Hospira | October 29, 1982 | 16, latest January 26, 2015 2015: Manufacturing (CMC) · 2014: Manufacturing (CMC) · 2014: Manufacturing (CMC) |
| NDA018897 SODIUM CHLORIDE 14.6%, SODIUM CHLORIDE 23.4% | Hospira | July 20, 1984 | 18, latest June 18, 2020 2020: Manufacturing (CMC) · 2014: Manufacturing (CMC) · 2014: Manufacturing (CMC) |
| NDA019022 SODIUM CHLORIDE 3% IN PLASTIC CONTAINER, SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | Baxter Hlthcare | November 1, 1983 | 22, latest September 14, 2018 2018: Labeling · 2014: Labeling · 2014: Manufacturing (CMC) |
| NDA019319 SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER | Baxter Hlthcare | May 17, 1985 | 10, latest September 29, 2014 2014: Manufacturing (CMC) · 2007: Manufacturing (CMC) · 2001: Manufacturing (CMC) |
| NDA019465 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Hospira | July 15, 1985 | 35, latest May 29, 2019 2019: Manufacturing (CMC) · 2016: Labeling · 2016: Labeling |
| NDA019635 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE 0.9%, SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE 3% IN PLASTIC CONTAINER, SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | B Braun | March 9, 1988 | 26, latest April 26, 2016 2016: Manufacturing (CMC) · 2015: Manufacturing (CMC) · 2015: Manufacturing (CMC) |
| NDA020178 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Baxter Hlthcare | December 7, 1992 | 11, latest December 7, 2022 2022: Manufacturing (CMC) · 2020: Manufacturing (CMC) · 2019: Labeling |
| NDA021569 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Liebel-Flarsheim | July 27, 2006 | 5, latest December 29, 2018 2018: Labeling · 2013: Manufacturing (CMC) · 2012: Labeling |
| NDA202832 SODIUM CHLORIDE 0.9% | Medefil Inc | January 6, 2012 | 3, latest October 26, 2022 2022: Labeling · 2017: Labeling · 2012: Labeling |
Generic approvals (14)
- ANDA088912Fresenius Kabi USA · January 10, 1985
- ANDA088911Fresenius Kabi USA · February 7, 1985
- ANDA078177Fresenius Medcl · April 12, 2007
- ANDA201833Hikma · September 24, 2013
- ANDA207956Laboratorios Grifols · May 25, 2017
- ANDA206171Spectra Mdcl Devices · July 21, 2017
- ANDA207310Fresenius Kabi USA · September 19, 2017
- ANDA208122Fresenius Kabi USA · July 23, 2018
- ANDA209476Fresenius Kabi USA · March 13, 2019
- ANDA211968Nephron · April 23, 2020
- ANDA212070Fresenius Kabi USA · April 28, 2021
- ANDA212248Fresenius Kabi USA · April 28, 2021
- ANDA217796Fresenius Kabi USA · July 11, 2023
- ANDA213688Fresenius Kabi USA · June 24, 2024
Shortage status
To be discontinued · updated December 3, 2025 · first posted December 3, 2025
| Product | Sodium Chloride 0.9%, Injection, 250 mL ADD-Vantage® Flexible Container (NDC 0409-7101-02) |
|---|---|
| Company | Hospira, Inc., a Pfizer Company |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
August 19, 2026 · Class I · Ongoing · D-0869-2026
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018 USA, NDC 0264-1800-32. — B BRAUN MEDICAL INC
-
August 17, 2026 · Class I · Ongoing · D-0849-2026
Presence of particulate matter: Particulates identified as fiberglass
0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, Made in USA, NDC 0338-0049-03 — Baxter Healthcare Corporation
-
April 2, 2026 · Class II · Ongoing · D-0497-2026
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60. — B BRAUN MEDICAL INC
-
April 2, 2026 · Class II · Ongoing · D-0531-2026
Lack of Assurance of Sterility
0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-151 — Huons Co., Ltd.
-
March 11, 2026 · Class II · Ongoing · D-0427-2026
Lack of Assurance of Sterility
0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-470-05, Unit of — Fresenius Kabi USA, LLC
-
March 11, 2026 · Class II · Ongoing · D-0424-2026
Lack of Assurance of Sterility
0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Un — Fresenius Kabi USA, LLC
-
March 11, 2026 · Class II · Ongoing · D-0434-2026
Lack of Assurance of Sterility
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactu — Fresenius Kabi USA, LLC
-
March 11, 2026 · Class II · Ongoing · D-0428-2026
Lack of Assurance of Sterility
0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of — Fresenius Kabi USA, LLC
-
March 11, 2026 · Class II · Ongoing · D-0430-2026
Lack of Assurance of Sterility
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manuf — Fresenius Kabi USA, LLC
-
March 11, 2026 · Class II · Ongoing · D-0433-2026
Lack of Assurance of Sterility
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical Care RTG, LLC, Manufa — Fresenius Kabi USA, LLC
-
March 11, 2026 · Class II · Ongoing · D-0425-2026
Lack of Assurance of Sterility
0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale NDC Number: 65219-4 — Fresenius Kabi USA, LLC
-
March 11, 2026 · Class II · Ongoing · D-0426-2026
Lack of Assurance of Sterility
0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 600047, Unit of Use NDC: 65219-468-05, Uni — Fresenius Kabi USA, LLC
-
March 11, 2026 · Class II · Ongoing · D-0429-2026
Lack of Assurance of Sterility
0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC — Fresenius Kabi USA, LLC
-
March 11, 2026 · Class II · Ongoing · D-0431-2026
Lack of Assurance of Sterility
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactur — Fresenius Kabi USA, LLC
-
March 11, 2026 · Class II · Ongoing · D-0432-2026
Lack of Assurance of Sterility
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of Use NDC: 65219-432-20 — Fresenius Kabi USA, LLC
-
October 27, 2025 · Class II · Ongoing · D-0143-2026
Lack of Assurance of Sterility: Potential for flexible container leaks.
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37 — Otsuka ICU Medical LLC
-
August 26, 2025 · Class II · Ongoing · D-0653-2025
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60. — B BRAUN MEDICAL INC
-
August 18, 2025 · Class I · Ongoing · D-0628-2025
Presence of Particulate Matter.
0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09 — B BRAUN MEDICAL INC
-
August 4, 2025 · Class II · Ongoing · D-0586-2025
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00. — B BRAUN MEDICAL INC
-
June 16, 2025 · Class II · Ongoing · D-0491-2025
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10. — B BRAUN MEDICAL INC
-
May 27, 2025 · Class II · Ongoing · D-0490-2025
Lack of Assurance of Sterility
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10 — Fresenius Medical Care Holdings, Inc.
-
March 31, 2025 · Class II · Ongoing · D-0353-2025
Presence of Particulate Matter
0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-2201-10 — B. Braun Medical Inc
-
July 24, 2024 · Class I · Ongoing · D-0638-2024
Presence of Particulate Matter
0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09. — B. Braun Medical Inc
-
August 2, 2023 · Class III · Terminated · D-1083-2023
Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00 — B. Braun Medical Inc.
-
July 5, 2023 · Class II · Terminated · D-0916-2023
Lack of assurance of sterility: bags have the potential to leak.
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00 — B. Braun Medical Inc.
Showing the newest 25 of 72.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 313002, 313016, 486515, 727820, 730781, 730782, 1807547, 1807548, 1807549, 1807550 … (+10) |
|---|---|
| SPL set ID of the quoted label | 376093e7-e09e-4a57-3199-195e45251866 |
| FDA labels (SPL) | 81 |
| FDA applications | NDA016366, NDA016677, NDA016733, NDA017427, NDA017464, NDA017867, NDA018016, NDA018090, NDA018314, NDA018800, NDA018803, NDA018897, NDA019022, NDA019319, NDA019465, NDA019635, NDA020178, NDA021569, NDA202832, 14 ANDA |
| Active ingredients (FDA) | SODIUM CHLORIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Bacteriostatic Sodium Chloride, Hospira, Inc., effective April 3, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →