Active ingredient
Amikacin
12 finished FDA listings contain Amikacin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- AMIKACIN, AMIKACIN SULFATE
- Dosage forms
- Injection, Injection, Solution, Suspension
- Routes
- Intramuscular, Intravenous, Respiratory (Inhalation)
- Manufacturers / labelers
- 7
- Strengths listed
- 1 g/4ml · 250 mg/ml · 500 mg/2ml · 590 mg/8.4ml
- Brand names in FDA listings
- Arikayce
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 641
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 |
|---|---|---|---|
| ANDA 063315 | HIKMA | 1994-04-11 | 2 |
| ANDA 204040 | AVET LIFESCIENCES | 2013-12-12 | 3 |
| ANDA 205604 | FRESENIUS KABI USA | 2015-12-09 | 1 |
| ANDA 203323 | SAGENT PHARMS INC | 2016-05-12 | 1 |
| NDA 207356 | INSMED INC | 2018-09-28 | 1 |
| ANDA 218146 | QILU | 2024-03-19 | 4 |
Official labeling on DailyMed
- ARIKAYCE (AMIKACIN) SUSPENSION [INSMED INCORPORATED] · version 17 · 2026-08-10
- AMIKACIN SULFATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] · version 10 · 2026-08-03
- AMIKACIN SULFATE INJECTION [MULLAN PHARMACEUTICAL INC.] · version 2 · 2026-01-14
- AMIKACIN SULFATE INJECTION, SOLUTION [QILU PHARMACEUTICAL CO., LTD.] · version 3 · 2025-12-11
- AMIKACIN SULFATE INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] · version 20 · 2025-06-25
- AMIKACIN SULFATE INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] · version 4 · 2025-06-23
- AMIKACIN SULFATE INJECTION [HIKMA PHARMACEUTICALS USA INC.] · version 10 · 2024-04-10
- AMIKACIN SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC · version 8 · 2023-07-07
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.