Active substance
Nafcillin
- US FDA 26
- WHO EML 1
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| NALLPEN IN PLASTIC CONTAINER | EQ 2GM BASE/100ML | injectable · injection | BAXTER HLTHCARE | Prescription | 31 Oct 1989 |
| NAFCILLIN SODIUM | EQ 10GM BASE/VIAL | injectable · injection | ISTITUTO BIO ITA SPA | Prescription | 20 Apr 2011 |
| NAFCILLIN SODIUM | EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL | injectable · injection | ACS DOBFAR SPA | Prescription | 30 Jun 2011 |
| NAFCILLIN SODIUM | EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL | injectable · injection | ANTIBIOTICE | Prescription | 3 Oct 2011 |
| NAFCILLIN SODIUM | EQ 10GM BASE/VIAL | injectable · injection | SAGENT PHARMS | Prescription | 24 Aug 2012 |
| NAFCILLIN SODIUM | EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL | injectable · injection | SAGENT PHARMS | Prescription | 24 Aug 2012 |
| NAFCILLIN SODIUM | EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL | injectable · injection | EUGIA PHARMA SPECLTS | Prescription | 26 Dec 2012 |
| NAFCILLIN SODIUM | EQ 10GM BASE/VIAL | injectable · injection | EUGIA PHARMA SPECLTS | Prescription | 26 Dec 2012 |
| NAFCILLIN SODIUM | EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL | injectable · injection | ONESOURCE SPECIALTY | Prescription | 7 Apr 2014 |
| NAFCILLIN SODIUM | EQ 10GM BASE/VIAL | injectable · injection | STERISCIENCE | Prescription | 25 Sep 2026 |
| UNIPEN | EQ 250MG BASE/5ML | for solution · oral | WYETH AYERST | Discontinued | 11 Oct 1965 |
| UNIPEN | EQ 250MG BASE | capsule · oral | WYETH AYERST | Discontinued | 7 Apr 1970 |
| UNIPEN | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 4GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 20GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | WYETH AYERST | Discontinued | 23 Jun 1970 |
| UNIPEN IN PLASTIC CONTAINER | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | WYETH AYERST | Discontinued | 23 Jun 1970 |
| UNIPEN | EQ 500MG BASE | tablet · oral | WYETH AYERST | Discontinued | 16 Oct 1973 |
| NAFCILLIN SODIUM | EQ 500MG BASE/VIAL; EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL; EQ 10GM BASE/VIAL | injectable · injection | SANDOZ | Discontinued | 2 Aug 1984 |
| NALLPEN | EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL | injectable · injection | GLAXOSMITHKLINE | Discontinued | 19 Dec 1986 |
| NAFCILLIN SODIUM | EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL | injectable · injection | SANDOZ | Discontinued | 23 Dec 1986 |
| NAFCILLIN SODIUM | EQ 10GM BASE/VIAL | injectable · injection | WATSON LABS INC | Discontinued | 29 Sep 1988 |
| NAFCILLIN SODIUM | EQ 500MG BASE/VIAL; EQ 1GM BASE/VIAL; EQ 1.5GM BASE/VIAL; EQ 2GM BASE/VIAL; EQ 4GM BASE/VIAL | injectable · injection | WATSON LABS INC | Discontinued | 26 Oct 1988 |
| NALLPEN IN PLASTIC CONTAINER | EQ 20MG BASE/ML | injectable · injection | BAXTER HLTHCARE | Discontinued | 31 Oct 1989 |
| NAFCILLIN SODIUM | EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL | injectable · injection | FRESENIUS | Discontinued | 10 Dec 2019 |
| NAFCILLIN SODIUM | EQ 10GM BASE/VIAL | injectable · injection | FRESENIUS | Discontinued | 2 Jun 2020 |
| NAFCILLIN SODIUM | EQ 500MG BASE/VIAL; EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL; EQ 4GM BASE/VIAL | injectable · injection | APOTHECON | Discontinued | |
| NALLPEN | EQ 500MG BASE/VIAL; EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL; EQ 10GM BASE/VIAL | injectable · injection | GLAXOSMITHKLINE | Discontinued |
1 more — full table
WHO WHO Model List of Essential Medicines (2025)
- 6.2.1. Access group antibiotics · core
First choice: Therapeutic equivalent to cloxacillin for Bacterial infection of joint; First choice: Therapeutic equivalent to cloxacillin for Osteomyelitis or osteitis; First choice: Therapeutic equivalent to cloxacillin for Bacterial cellulitis, erysipelas or lymphangitis; Second choice: Therapeutic equivalent to cloxacillin for Sepsis without septic shock
Safety signals and safety-related labeling changes
- US FDA 5 Apr 2018 NALLPEN IN PLASTIC CONTAINER — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions - EMA PRAC 14 Apr 2016 PRAC signal: Metabolic acidosis following administration of flucloxacillin in association with paracetamol
Action for MAH: update of the product information: No
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.