Ceftriaxone Sodium

Sold as Rocephin, Rocephin W/ Dextrose In Plastic Container, Ceftriaxone And Dextrose In Duplex Container. Every FDA application for this active ingredient: 3 branded and 39 generic.

As of Nov 15, 2026, FDA lists 42 applications for Ceftriaxone Sodium (sold as Rocephin, Rocephin W/ Dextrose In Plastic Container, Ceftriaxone And Dextrose In Duplex Container), first approved Dec 21, 1984, with 7 new uses approved and 0 published complete response letters.

First approved: Dec 21, 1984
Applications: 42
New uses approved: 7
Complete response letters: 0

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

CEFTRIAXONE 1 GM VIAL: $1.46 per unitGeneric · -1% in a year
CEFTRIAXONE 2 GM VIAL: $2.79 per unitGeneric · +23% in a year
CEFTRIAXONE 250 MG VIAL: $0.862 per unitGeneric · -31% in a year
CEFTRIAXONE 500 MG VIAL: $1.86 per unitGeneric · -7% in a year

Orphan Designations (FDA)

One designation, 0 approved for the designated use; see all orphan designations

Treatment of amyotrophic lateral sclerosisMass General Hospital · designated Mar 28, 2006

Shortages

FDA's drug shortage list, as of Nov 13, 2026

Shortage	Status	First posted	Updated
Ceftriaxone Sodium Injection	To Be Discontinued	Oct 30, 2026	Oct 30, 2026

Clinical Trials

41 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


All-Oral Fluoroquinolone-Based Triple Therapies for Adults With Imaging-Confirmed Osteoarticular BrucellosisBrucellosis, Osteoarticular Brucellosis · The First Affiliated Hospital of Shihezi University	Not applicable	Not yet recruiting	Oct 21, 2026
Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated AppendicitisAppendicitis Perforated, Appendectomy, Laparoscopic · McMaster Children's Hospital	Phase 3	Not yet recruiting	Oct 9, 2026
Oral Care Interventions in PEG-Fed Palliative Care PatientsOral Mucosal Integrity, Palliative Care · University of Yalova	Not applicable	Not yet recruiting	Aug 28, 2026
500-mg Versus 1000-mg Ceftriaxone for Uncomplicated Gonorrhea InfectionGonorrhea Infection · National Taiwan University Hospital	Phase 3	Recruiting	Jul 17, 2026
INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionSDrug Resistance, Microbial, Biomarkers · University Hospital, Limoges	Not applicable	Recruiting	Jun 30, 2026
Efficacy of Temocillin Compared to Standard of Care in the Treatment of Neisseria Gonorrhoeae InfectionsNeisseria Gonorrhoeae (Ng) Infections · Assistance Publique - Hôpitaux de Paris	Phase 3	Not yet recruiting	Jun 8, 2026
Ceftriaxone Dosage for Non-Critical Community-Acquired PneumoniaCommunity Acquired Pneumonia (CAP) · University of Maryland, Baltimore	Phase 4	Not yet recruiting	Apr 17, 2026
Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform TrialMycobacterium Abscessus Pulmonary Disease, Mycobacterium Abscessus Infection · The University of Queensland	Phase 2	Not yet recruiting	Mar 20, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Dec 21, 1984	RocephinNDA 50585 · New molecular entity	Hoffmann La Roche	46	Discontinued
Feb 11, 1987	Rocephin W/ Dextrose In Plastic ContainerNDA 50624 · New dosage form	Hoffmann La Roche	23	Discontinued
Apr 30, 1987	RocephinANDA 62654	Hoffmann La Roche	18	Discontinued
Aug 13, 1993	RocephinANDA 63239	Hoffmann La Roche	5	Discontinued
Sep 30, 2003	CeftriaxoneANDA 65125	Lupin	11	Discontinued
Apr 20, 2005	Ceftriaxone And Dextrose In Duplex ContainerNDA 50796 · New formulation or manufacturer	B Braun	12	Marketed
May 3, 2005	CeftriaxoneANDA 65204	Sandoz Inc	8	Discontinued
May 9, 2005	CeftriaxoneANDA 65169	Sandoz	8	Marketed
May 17, 2005	CeftriaxoneANDA 65168	Sandoz	7	Marketed
Aug 2, 2005	CeftriaxoneANDA 65231	Hospira Inc	6	Discontinued
Aug 2, 2005	CeftriaxoneANDA 65230	Hospira Inc	6	Discontinued
Aug 2, 2005	CeftriaxoneANDA 65232	Hospira Inc	6	Discontinued
Aug 23, 2005	Ceftriaxone In Plastic ContainerANDA 65224	Baxter Hlthcare	9	Marketed
Feb 15, 2006	CeftriaxoneANDA 65245	Fresenius Kabi USA	4	Discontinued
Feb 15, 2006	CeftriaxoneANDA 65252	Fresenius Kabi USA	2	Discontinued
May 1, 2006	CeftriaxoneANDA 65274	Teva	0	Discontinued
May 12, 2006	CeftriaxoneANDA 65180	Apotex	6	Marketed
Jun 29, 2006	CeftriaxoneANDA 65262	Teva	0	Discontinued
Sep 12, 2006	CeftriaxoneANDA 65263	Lupin	7	Discontinued
Feb 28, 2007	CeftriaxoneANDA 65268	Facta Farma	3	Discontinued
Feb 28, 2007	CeftriaxoneANDA 65269	Facta Farma	2	Discontinued
Mar 15, 2007	CeftriaxoneANDA 65227	Teva Pharms USA	0	Discontinued
Mar 26, 2007	CeftriaxoneANDA 65294	Cephazone Pharma	3	Discontinued
Apr 12, 2007	CeftriaxoneANDA 65391	Wockhardt Bio AG	6	Marketed
Jan 10, 2008	CeftriaxoneANDA 65342	Hikma Farmaceutica	7	Marketed
Jan 11, 2008	CeftriaxoneANDA 65305	Epic Pharma LLC	4	Marketed
Jul 24, 2008	CeftriaxoneANDA 65328	Acs Dobfar	11	Marketed
Jul 24, 2008	CeftriaxoneANDA 65329	Acs Dobfar	7	Marketed
Jul 31, 2008	CeftriaxoneANDA 65504	Aurobindo Pharma Ltd	0	Discontinued
Jul 31, 2008	CeftriaxoneANDA 65505	Aurobindo Pharma Ltd	0	Discontinued
Aug 18, 2008	CeftriaxoneANDA 65465	Bedford	5	Discontinued
Aug 18, 2008	CeftriaxoneANDA 65475	Bedford	6	Discontinued
Aug 20, 2012	CeftriaxoneANDA 202563	Hospira Inc	0	Discontinued
Jan 7, 2013	CeftriaxoneANDA 91068	Agila Speclts	1	Discontinued
Apr 25, 2014	CeftriaxoneANDA 90057	Samson Medcl	2	Marketed
Jun 29, 2016	CeftriaxoneANDA 203702	Qilu Antibiotics	2	Marketed
Jan 20, 2017	Ceftriaxone SodiumANDA 91117	Anda Repository	1	Marketed
Oct 4, 2017	Ceftriaxone SodiumANDA 90701	Hikma	1	Marketed
Jun 11, 2018	CeftriaxoneANDA 91049	Astral	1	Discontinued
Oct 17, 2018	CeftriaxoneANDA 209218	Qilu Antibiotics	1	Marketed
Jan 12, 2024	CeftriaxoneANDA 210197	Regcon Holdings	0	Discontinued
—	RocephinANDA 62510	Roche	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