Quick answers
- What is Nafcillin sodium used for?
- The FDA-approved label (Nafcillin, Baxter Healthcare Corporation, December 6, 2024) says: “Nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see CLINICAL PHARMACOLOGY - Susceptibility Test Methods ). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Nafcillin sodium have a boxed warning?
- No. None of the 15 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Nafcillin sodium?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Nafcillin sodium been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Nafcillin sodium?
- 10 companies list prescription products of Nafcillin sodium in the FDA NDC Directory, including Eugia US LLC, Fresenius Kabi USA, LLC and Onesource Specialty Pharma Limited.
What Nafcillin sodium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see CLINICAL PHARMACOLOGY - Susceptibility Test Methods ). …
— FDA label: Nafcillin, Baxter Healthcare Corporation, effective December 6, 2024. Read the full label on DailyMed →
The FDA has 15 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.
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 15 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, for solution · Injection, powder, lyophilized, for solution · Injection, solution |
|---|---|
| Route | Intravenous · Intramuscular |
| Prescription products | 21 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.
- Eugia US LLC5 products
- Fresenius Kabi USA, LLC4 products
- Onesource Specialty Pharma Limited3 products
- WG Critical Care, LLC3 products
- Armas Pharmaceuticals Inc.2 products
- NorthStar Rx LLC2 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.2 products
- Sagent Pharmaceuticals1 product
- Avenacy Inc.1 product
- Baxter Healthcare Corporation1 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 |
|---|---|---|---|
| NDA050655 NALLPEN IN PLASTIC CONTAINER | Baxter Hlthcare | October 31, 1989 | 16, latest April 5, 2018 2018: Labeling · 2017: Labeling · 2015: Labeling |
Generic approvals (7)
- ANDA090005Istituto Bio Ita Spa · April 20, 2011
- ANDA090002Acs Dobfar Spa · June 30, 2011
- ANDA090560Antibiotice · October 3, 2011
- ANDA091613Eugia Pharma Speclts · December 26, 2012
- ANDA091614Eugia Pharma Speclts · December 26, 2012
- ANDA200002Onesource Specialty · April 7, 2014
- ANDA203830Steriscience · September 25, 2026
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) | 239189, 1721458, 1721460 |
|---|---|
| SPL set ID of the quoted label | cd2d18c5-95a2-4fb4-bd8b-b5d39e2da416 |
| FDA labels (SPL) | 15 |
| FDA applications | NDA050655, 7 ANDA |
| Active ingredients (FDA) | NAFCILLIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Nafcillin, Baxter Healthcare Corporation, effective December 6, 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 →