Quick answers
- What is Cefuroxime used for?
- The FDA-approved label (Cefuroxime and Dextrose, B. Braun Medical Inc., December 5, 2020) says: “Cefuroxime for Injection USP and Dextrose Injection USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cefuroxime have a boxed warning?
- No. None of the 6 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Cefuroxime?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Cefuroxime been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Cefuroxime?
- 3 companies list prescription products of Cefuroxime in the FDA NDC Directory, including Hikma Pharmaceuticals USA Inc., Sagent Pharmaceuticals and B. Braun Medical Inc..
What Cefuroxime is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Cefuroxime for Injection USP and Dextrose Injection USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases …
— FDA label: Cefuroxime and Dextrose, B. Braun Medical Inc., effective December 5, 2020. Read the full label on DailyMed →
The FDA has 6 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.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 6 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, for solution · Injection, solution |
|---|---|
| Route | Intravenous · Intramuscular |
| Prescription products | 10 in the FDA NDC Directory |
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.
- Hikma Pharmaceuticals USA Inc.6 products
- Sagent Pharmaceuticals2 products
- B. Braun Medical Inc.2 products
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 |
|---|---|---|---|
| NDA050780 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER | B Braun | February 21, 2001 | 7, latest December 5, 2020 2020: Labeling · 2015: Labeling · 2013: Manufacturing (CMC) |
Generic approvals (3)
- ANDA064125Acs Dobfar Spa · May 30, 1997
- ANDA065046Hikma · January 9, 2004
- ANDA065048Hikma · January 9, 2004
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 309101, 1665444, 1665449 |
|---|---|
| SPL set ID of the quoted label | 07170ee3-1a24-424f-a2a2-00bc92e98f85 |
| FDA labels (SPL) | 6 |
| FDA applications | NDA050780, 3 ANDA |
| Active ingredients (FDA) | CEFUROXIME |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cefuroxime and Dextrose, B. Braun Medical Inc., effective December 5, 2020; 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 →