Tools / Drug approvals and letters / Drugs Sodium Chloride For restricted oral intake. Sold as Sodium Chloride 0.9% In Plastic Container, Sodium Chloride, Sodium Chloride 0.45% In Plastic Container, Sodium Chloride In Plastic Container, Bacteriostatic Sodium Chloride 0.9% In Plastic Container and 9 more. Every FDA application for this active ingredient: 36 branded and 20 generic.
As of Nov 15, 2026, FDA lists 56 applications for Sodium Chloride (sold as Sodium Chloride 0.9% In Plastic Container, Sodium Chloride, Sodium Chloride 0.45% In Plastic Container and others), first approved Aug 12, 1970, with 0 new uses approved and 0 published complete response letters.
First approved : Aug 12, 1970 Applications : 56 New uses approved : 0 Complete response letters : 0 Medicare spending, 2025 : $10.9M
Medicare Spending CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name Product Part Spending, 2025 Change Beneficiaries Sodium Chloride Part D $10.9M +15% 161,602
Shortages FDA's drug shortage list, as of Nov 13, 2026 Clinical Trials 3,789 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all Study Phase Status Posted Vitamin D3 Versus Methotrexate Versus Saline Injections for Plantar Warts Plantar Warts · Kafrelsheikh University Not applicable Recruiting Nov 13, 2026 A Phase II Study of Nab-Paclitaxel Combined With Retlirafusp Alfa and Apatinib in Patients With Advanced Mucosal Melanoma Melanoma, Immune Checkpoint Inhibitor · Sun Yat-sen University Phase 2 Recruiting Nov 13, 2026 Foley Catheter vs. Foley + Extra-amniotic Saline Infusion for Labor Induction at 41 Weeks and Beyond Labor Induction, Post-term Pregnancy · Ankara City Hospital Bilkent Not applicable Recruiting Nov 13, 2026 Silica-Based Wound Treatment (Curi01) Plus Standard Care Versus Standard Care Alone for Chronic Diabetic Foot Wounds Diabetic Foot Disease, Foot Ulcer Due to Type 1 Diabetes Mellitus · Cutempa Medical AG Not applicable Recruiting Nov 13, 2026 Dual Energy Focal Ablation of Premature Ventricular Complexes Premature Ventricular Contractions · Konstantinos Siontis Not applicable Not yet recruiting Nov 13, 2026 Intravenous LIGNOcaine for the POstoperative Sore Throat Postoperative Sore Throat, Cough, Hoarseness, Postoperative Complications · University of Malaya Phase 4 Not yet recruiting Nov 13, 2026 Intranasal Esketamine-dexmedetomidine Combination in Patients With Postherpetic Neuralgia Postherpetic Neuralgia, Esketamine · Peking University First Hospital Phase 4 Not yet recruiting Nov 13, 2026 Repurposing Insulin With Intranasal Administration to Improve Function After Mild Traumatic Brain Injury Concussion (Diagnosis), Mild Traumatic Brain Injury · HealthPartners Institute Phase 2 Recruiting Nov 13, 2026
Applications NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history Approved Application Sponsor Supplements Marketing Aug 12, 1970 Sodium Chloride 0.9% In Plastic Container NDA 16733 · New formulation or manufacturer 48 Marketed Dec 9, 1970 Sodium Chloride 0.9% In Plastic Container NDA 16677 · New formulation or manufacturer 103 Marketed Oct 7, 1971 Sodium Chloride NDA 17038 · New formulation or manufacturer 1 Discontinued Oct 8, 1971 Sodium Chloride NDA 17013 · New formulation or manufacturer 11 Discontinued Feb 24, 1972 Sodium Chloride 0.9% In Plastic Container NDA 16366 · New formulation or manufacturer 142 Marketed Apr 8, 1974 Sodium Chloride 0.9% In Plastic Container NDA 17514 · New formulation or manufacturer 47 Marketed Dec 31, 1974 Sodium Chloride 0.9% In Plastic Container NDA 17427 · New formulation or manufacturer 57 Marketed Mar 10, 1975 Sodium Chloride 0.45% In Plastic Container NDA 17670 · New formulation or manufacturer 37 Discontinued Feb 8, 1978 Sodium Chloride 0.9% In Plastic Container NDA 17464 · New formulation or manufacturer 38 Marketed Feb 2, 1979 Sodium Chloride 0.45% In Plastic Container NDA 18016 · New formulation or manufacturer 48 Marketed Apr 4, 1979 Sodium Chloride 0.45% In Plastic Container NDA 18090 · New formulation or manufacturer 75 Marketed Jun 8, 1979 Sodium Chloride 0.45% In Plastic Container NDA 18184 14 Discontinued Feb 22, 1980 Sodium Chloride 0.9% In Plastic Container NDA 18314 · New formulation or manufacturer 46 Marketed May 30, 1980 Sodium Chloride 0.45% In Plastic Container NDA 17864 · New formulation or manufacturer 36 Discontinued May 30, 1980 Sodium Chloride 0.9% In Plastic Container NDA 17867 · New formulation or manufacturer 42 Marketed Aug 5, 1980 Sodium Chloride 0.45% In Plastic Container NDA 18380 · New formulation or manufacturer 35 Discontinued Oct 29, 1982 Bacteriostatic Sodium Chloride 0.9% In Plastic Container NDA 18800 · New formulation or manufacturer 14 Marketed Oct 29, 1982 Sodium Chloride 0.9% In Plastic Container NDA 18803 · New formulation or manufacturer 16 Marketed Nov 1, 1983 Sodium Chloride 3% In Plastic Container, Sodium Chloride 5% In Plastic Container NDA 19022 · New formulation or manufacturer 22 Marketed Jul 13, 1984 Sodium Chloride 0.9% In Plastic Thermoject Kit For Cardiac Output Use, Sodium Chloride 0.9% In Plastic Container NDA 19217 · New formulation or manufacturer 5 Discontinued Jul 20, 1984 Sodium Chloride 14.6%, Sodium Chloride 23.4% NDA 18897 · New formulation or manufacturer 18 Marketed Jan 10, 1985 Sodium Chloride 0.9% In Plastic Container ANDA 88912 15 Marketed Feb 7, 1985 Bacteriostatic Sodium Chloride 0.9% In Plastic Container ANDA 88911 8 Marketed May 17, 1985 Sodium Chloride 0.9% In Sterile Plastic Container NDA 19319 · New formulation or manufacturer 10 Marketed Jul 15, 1985 Sodium Chloride 0.9% In Plastic Container NDA 19465 · New formulation or manufacturer 35 Marketed Sep 17, 1985 Sodium Chloride 0.9% In Plastic Container NDA 19480 · New formulation or manufacturer 29 Marketed Mar 9, 1988 Sodium Chloride 0.45% In Plastic Container, Sodium Chloride 0.9% In Plastic Container NDA 19635 · New formulation or manufacturer 26 Marketed Jun 8, 1988 Sodium Chloride 0.45% In Plastic Container NDA 19759 · New formulation or manufacturer 31 Marketed Sep 3, 1992 Broncho Saline NDA 19912 · New formulation or manufacturer 0 Discontinued Dec 7, 1992 Sodium Chloride 0.9% In Plastic Container NDA 20178 · New formulation or manufacturer 11 Marketed Oct 27, 2004 Sodium Chloride 0.9% In Plastic Container ANDA 76316 0 Marketed Jul 27, 2006 Sodium Chloride 0.9% In Plastic Container NDA 21569 · New formulation or manufacturer 5 Marketed Aug 11, 2006 Sodium Chloride 0.9% In Plastic Container ANDA 77407 0 Marketed Apr 12, 2007 Sodium Chloride 0.9% In Plastic Container ANDA 78177 2 Marketed Jan 6, 2012 Sodium Chloride 0.9% NDA 202832 · New formulation or manufacturer 3 Marketed Jan 20, 2012 Sodium Chloride 0.9% ANDA 201850 0 Discontinued Sep 24, 2013 Sodium Chloride 0.9% ANDA 201833 0 Marketed May 18, 2016 Sodium Chloride 0.9% In Plastic Container ANDA 203352 0 Discontinued May 25, 2017 Sodium Chloride 0.9% In Plastic Container ANDA 207956 2 Marketed Jul 21, 2017 Sodium Chloride 0.9% ANDA 206171 0 Marketed Sep 19, 2017 Sodium Chloride 0.9% In Plastic Container ANDA 207310 4 Marketed Jul 23, 2018 Sodium Chloride 0.45% In Plastic Container ANDA 208122 3 Marketed Mar 13, 2019 Sodium Chloride 3% In Plastic Container ANDA 209476 0 Marketed Apr 23, 2020 Sodium Chloride 0.9% In Plastic Container ANDA 211968 0 Marketed Apr 28, 2021 Sodium Chloride 14.6%, Sodium Chloride 23.4% ANDA 212070 0 Marketed Apr 28, 2021 Sodium Chloride 23.4% ANDA 212248 0 Marketed Jul 11, 2023 Sodium Chloride 23.4% ANDA 217796 0 Marketed Aug 23, 2023 Sodium Chloride 0.9% ANDA 217535 0 Marketed Jun 24, 2024 Sodium Chloride 0.9% In Plastic Container ANDA 213688 0 Marketed — Sodium Chloride In Plastic Container NDA 18247 0 Discontinued — Sodium Chloride 0.9% In Plastic Container NDA 18502 0 Discontinued — Sodium Chloride 0.45% In Plastic Container NDA 18503 0 Discontinued — Sodium Chloride 0.45% In Plastic Container NDA 18497 0 Discontinued — Sodium Chloride 0.9% In Plastic Container NDA 19218 0 Discontinued — Sodium Chloride 23.4% In Plastic Container NDA 19329 0 Discontinued — Bacteriostatic Sodium Chloride 0.9% In Plastic Container ANDA 88909 0 Discontinued
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Baxter Hlthcare
Abbott
Fresenius Kabi USA
Taro
Hikma
Nephron
Abraxis Pharm