Quick answers
- What is Cefoxitin used for?
- The FDA-approved label (Cefoxitin and Dextrose, B. Braun Medical Inc., July 29, 2019) says: “Cefoxitin for Injection and Dextrose Injection is a cephalosporin antibacterial indicated for the treatment of the following infections caused by susceptible isolates of the designated bacteria: Lower respiratory tract infections; Urinary tract infections; Intra-abdominal infections; Gynecological infections; Septicemia; Bone and joint infections; Skin and skin structure infections; Prophylaxis. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cefoxitin have a boxed warning?
- The label we quote has no boxed warning, but 3 of 11 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Cefoxitin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Cefoxitin been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started November 21, 2013 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Cefoxitin?
- 6 companies list prescription products of Cefoxitin in the FDA NDC Directory, including WG Critical Care, LLC, Fresenius Kabi USA, LLC and Sagent Pharmaceuticals.
What Cefoxitin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Cefoxitin for Injection and Dextrose Injection is a cephalosporin antibacterial indicated for the treatment of the following infections caused by susceptible isolates of the designated bacteria: Lower respiratory tract infections; Urinary tract infections; Intra-abdominal infections; Gynecological infections; Septicemia; Bone and joint infections; Skin and skin structure infections; Prophylaxis. …
— FDA label: Cefoxitin and Dextrose, B. Braun Medical Inc., effective July 29, 2019. Read the full label on DailyMed →
The FDA has 11 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.
3 of 11 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, for solution · Powder, for solution · Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 14 in the FDA NDC Directory |
| Brand names | Cefoxitin and Dextrose |
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.
- WG Critical Care, LLC5 products
- Fresenius Kabi USA, LLC4 products
- Sagent Pharmaceuticals3 products
- Hikma Pharmaceuticals USA Inc.3 products
- B. Braun Medical Inc.2 products
- Samson Medical Technologies LLC1 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 |
|---|---|---|---|
| NDA065214 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER | B Braun | March 10, 2006 | 6, latest July 29, 2019 2019: Labeling · 2013: Labeling · 2012: Manufacturing (CMC) |
Generic approvals (5)
- ANDA065414Acs Dobfar · June 12, 2009
- ANDA065239Hikma Farmaceutica · February 26, 2010
- ANDA065238Hikma Farmaceutica · March 12, 2010
- ANDA065415Acs Dobfar · May 19, 2010
- ANDA200938Samson Medcl · November 16, 2015
Shortage status
The FDA drug shortage list does not show these products.
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.
-
November 21, 2013 · Class I · Terminated · D-1264-2014
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog No. 3123-11, For IV Use Only, Single Use, Sterile, Rx Only, B Braun Medical Inc, Irvine CA 92614-5895, NDC 0264-3123-11 — B. Braun Medical Inc
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) | 309072, 1665102, 1665107, 1739890 |
|---|---|
| SPL set ID of the quoted label | 6c7e9485-1ede-411c-8c46-911439332864 |
| FDA labels (SPL) | 11 |
| FDA applications | NDA065214, 5 ANDA |
| Active ingredients (FDA) | CEFOXITIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cefoxitin and Dextrose, B. Braun Medical Inc., effective July 29, 2019; 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 →