Prescription medicine
Ceftriaxone First approved as Rocephin
Ceftriaxone (Rocephin) is a prescription medicine with an FDA approval on record since 1984. FDA's NDC Directory lists it from 16 generic labelers, and pharmacies paid $1.44 per ceftriaxone 1 g vial in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the ceftriaxone FDA label on DailyMed (effective February 4, 2026, Qilu Pharmaceutical Co., Ltd.); the NDA 50585 record on Drugs@FDA; every ceftriaxone label on DailyMed.
Highlights of the record
FDA label of February 4, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageBefore instituting treatment with Ceftriaxone for injection, USP, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug.
Forms and strengths
- 1 g
- 2 g
- 10 g
- 100 g
- 250 mg
- 500 mg
- 1 g/50ml
- 2 g/50ml
- 10 g/100ml
Injection (powder) for solution; injection (solution).
On the market
- Earliest approval on file
- December 21, 1984 Rocephin Kit, Hoffmann La Roche; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 38 first April 30, 1987; 14 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 17 of which 16 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $1.44 per vial Ceftriaxone 1 g vial
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 20 since 2015 4 Class I among all firms' recalls; latest May 15, 2023; 7 more by firms not listed as its makers
- FAERS reports
- 38,242 through July 30, 2026
What is ceftriaxone used for?
From the label: indications and usageBefore instituting treatment with Ceftriaxone for injection, USP, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceftriaxone for injection, USP and other antibacterial drugs, Ceftriaxone for injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. […]
Conditions named in the indications of ceftriaxone's FDA labels, with every medicine labeled for each:
From other ceftriaxone labelsUrinary tract infections: URINARY TRACT INFECTIONS (complicated and uncomplicated) caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella pneumoniae.
Bacterial infections: When administered prior to surgical procedures for which it is indicated, a single 1 gm dose of ceftriaxone provides protection from most infections due to susceptible organisms throughout the course of the procedure.
FDA pharmacologic class: Cephalosporin Antibacterial.
Source: FDA drug label (Ceftriaxone Sodium), Qilu Pharmaceutical Co., Ltd., effective February 4, 2026 (SPL set 4cdf0743-c62b-4969-b9c9-4c6400644f6c), via openFDA; the full label on DailyMed
Is there a generic for ceftriaxone (Rocephin)?
The FDA approved the first generic ceftriaxone on April 30, 1987. 38 generic applications are approved; 14 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists ceftriaxone from 16 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1984 earliest approval on file
- 1987 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ceftriaxone (Rocephin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.44 per Ceftriaxone 1 g vial, down 4% from $1.50 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Ceftriaxone 1 g vial (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ceftriaxone 1 g vial | Generic | $1.44 per vial | n/a | -4% |
| Ceftriaxone 2 g vial | Generic | $2.83 per vial | n/a | +22% |
| Ceftriaxone 250 mg vial | Generic | $0.862 per vial | n/a | +2% |
| Ceftriaxone 500 mg vial | Generic | $1.31 per vial | n/a | +17% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has ceftriaxone been recalled?
The FDA's Enforcement Report lists 27 recalls naming ceftriaxone since 2015: 4 Class I (the most serious), 16 Class II, 7 Class III; 0 still ongoing. 7 of them are by firms that FDA's NDC Directory does not list as a maker of ceftriaxone and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 15, 2023 | Class II | Astral SteriTech Private Ltd. | Lack of Assurance of Sterility |
| December 27, 2022 | Class II | Sentara Infusion Services not a listed maker | Lack of sterility assurance |
| December 20, 2018 | Class I | Lupin Pharmaceuticals Inc. | Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in … |
| October 19, 2016 | Class III | Sandoz Inc | Labeling: Missing Label |
| June 1, 2016 | Class III | Aidarex Pharmaceuticals LLC not a listed maker | CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API. |
| March 11, 2016 | Class III | Lupin Pharmaceuticals Inc. | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. |
| March 11, 2016 | Class III | Lupin Pharmaceuticals Inc. | CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications. |
| November 10, 2015 | Class II | Walgreens Infusion Services not a listed maker | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the ceftriaxone label say about other medicines?
The ceftriaxone label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 6 other medicines name ceftriaxone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Epinephrine | warnings | Serious acute hypersensitivity reactions may require the use of subcutaneous epinephrine and other emergency measures. |
| Fluconazole | drug interactions | DRUG INTERACTIONS Vancomycin, amsacrine, aminoglycosides, and fluconazole are physically incompatible. ( 7.1 ) Calcium-containing products: precipitation can occur. |
| Lidocaine | contraindications | Lidocaine Intravenous administration of ceftriaxone solutions containing lidocaine is contraindicated. |
| Vancomycin | drug interactions | DRUG INTERACTIONS Vancomycin, amsacrine, aminoglycosides, and fluconazole are physically incompatible. ( 7.1 ) Calcium-containing products: precipitation can occur. |
Other labels that name ceftriaxone
Source: FDA drug label (Ceftriaxone Sodium), Qilu Pharmaceutical Co., Ltd., effective February 4, 2026 (SPL set 4cdf0743-c62b-4969-b9c9-4c6400644f6c), via openFDA; the full label on DailyMed
What do FAERS reports show for ceftriaxone?
The FDA Adverse Event Reporting System holds 38,242 reports that list ceftriaxone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6,775 are coded as a death and 20,954 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
How does ceftriaxone compare with medicines for the same use?
14 side-by-side pages set ceftriaxone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to ceftriaxone
- medicines labeled for the same conditions
- Other cephalosporins
- the pharmacologic class, with prices and generics
- Ceftriaxone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other