Quick answers
- What is Cefotaxime used for?
- The FDA-approved label (Cefotaxime, Hikma Pharmaceuticals USA Inc., April 11, 2024) says: “Treatment Cefotaxime for Injection, USP is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cefotaxime have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Cefotaxime?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 14, 2026). Ask your pharmacist about alternatives.
- Has Cefotaxime been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Cefotaxime?
- 2 companies list prescription products of Cefotaxime in the FDA NDC Directory, including Hikma Pharmaceuticals USA Inc. and SteriMax Inc..
What Cefotaxime is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Treatment Cefotaxime for Injection, USP is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. …
— FDA label: Cefotaxime, Hikma Pharmaceuticals USA Inc., effective April 11, 2024. Read the full label on DailyMed →
The FDA has 2 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 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, for solution · Injection |
|---|---|
| Route | Intravenous · Intramuscular |
| Prescription products | 5 in the FDA NDC Directory |
| Brand names | Claforan |
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.4 products
- SteriMax Inc.1 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 |
|---|---|---|---|
| NDA050547 CLAFORAN | Sterimax | March 11, 1981 | 53, latest September 23, 2026 2026: Labeling · 2015: Labeling · 2014: Labeling |
Generic approvals (2)
- ANDA065071Hikma · November 20, 2002
- ANDA065072Hikma · November 20, 2002
Shortage status
Current shortage · updated October 14, 2026 · first posted February 17, 2015
| Product | Cefotaxime Sodium, Powder, for Solution, 2 g (NDC 0143-9933-25) |
|---|---|
| Availability | Unavailable |
| Reason given | Demand increase for the drug |
| Company | Hikma Pharmaceuticals USA, Inc. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 309065, 309068, 1656313, 1656318 |
|---|---|
| SPL set ID of the quoted label | ed23b6bc-32c7-4c50-a53d-313ae78e5623 |
| FDA labels (SPL) | 2 |
| FDA applications | NDA050547, 2 ANDA |
| Active ingredients (FDA) | CEFOTAXIME |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cefotaxime, Hikma Pharmaceuticals USA Inc., effective April 11, 2024; 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 →