Active ingredient
Nafcillin
23 finished FDA listings contain Nafcillin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- NAFCILLIN SODIUM
- Dosage forms
- Injection, Powder, For Solution, Injection, Powder, Lyophilized, For Solution, Injection, Solution
- Routes
- Intramuscular, Intravenous
- Manufacturers / labelers
- 10
- Strengths listed
- 1 g/1 · 1 g/4ml · 10 g/1 · 10 g/100ml · 2 g/1 · 2 g/100ml · 2 g/8ml
- Brand names in FDA listings
- Nafcillin
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 7233
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 050655 | BAXTER HLTHCARE | 1989-10-31 | 1 |
| ANDA 090005 | ISTITUTO BIO ITA SPA | 2011-04-20 | 5 |
| ANDA 090002 | ACS DOBFAR SPA | 2011-06-30 | 4 |
| ANDA 090560 | ANTIBIOTICE | 2011-10-03 | 4 |
| ANDA 091613 | EUGIA PHARMA SPECLTS | 2012-12-26 | 3 |
| ANDA 091614 | EUGIA PHARMA SPECLTS | 2012-12-26 | 2 |
| ANDA 200002 | ONESOURCE SPECIALTY | 2014-04-07 | 4 |
Official labeling on DailyMed
- NAFCILLIN INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC] · version 10 · 2026-08-31
- NAFCILLIN (NAFCILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A/ AVET PHARMACEUTICALS INC.] · version 3 · 2026-08-04
- NAFCILLIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] · version 20 · 2026-07-31
- NAFCILLIN SODIUM INJECTION, POWDER, FOR SOLUTION [ONESOURCE SPECIALTY PHARMA LIMITED] · version 2 · 2026-04-06
- NAFCILLIN SODIUM INJECTION, POWDER, FOR SOLUTION [ARMAS PHARMACEUTICALS INC.] · version 2 · 2025-12-08
- NAFCILLIN (NAFCILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [EUGIA US LLC] · version 6 · 2025-08-22
- NAFCILLIN (NAFCILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [EUGIA US LLC] · version 7 · 2025-08-22
- NAFCILLIN (NAFCILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [EUGIA US LLC] · version 14 · 2025-08-22
- NAFCILLIN (NAFCILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [EUGIA US LLC] · version 13 · 2025-08-22
- NAFCILLIN (NAFCILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [AVENACY INC.] · version 1 · 2025-02-03
- NAFCILLIN (NAFCILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [NORTHSTAR RX, LLC] · version 4 · 2024-07-12
- NAFCILLIN INJECTION, POWDER, FOR SOLUTION [NORTHSTAR RX, LLC] · version 1 · 2024-03-01
Showing the 12 most recent of 15 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.