Active ingredient
Aztreonam
11 finished FDA listings contain Aztreonam as their only active ingredient; 1 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- AZTREONAM
- Dosage forms
- Injection, Powder, For Solution, Injection, Powder, Lyophilized, For Solution
- Routes
- Intramuscular, Intravenous
- Manufacturers / labelers
- 4
- Strengths listed
- 1 g/1 · 2 g/1
- Brand names in FDA listings
- Azactam
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1272
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 050580 | LABS DELBERT | 1986-12-31 | 3 |
| ANDA 065439 | FRESENIUS KABI USA | 2010-06-18 | 6 |
| ANDA 206517 | HOSPIRA | 2021-11-08 | 2 |
Official labeling on DailyMed
- AZACTAM (AZTREONAM) INJECTION, POWDER, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.] · version 15 · 2025-12-23
- AZACTAM (AZTREONAM) INJECTION, POWDER, FOR SOLUTION [A-S MEDICATION SOLUTIONS] · version 1 · 2025-01-13
- AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] · version 3 · 2024-06-17
- AZTREONAM (AZTREONAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC · version 6 · 2022-06-06
- AZTREONAM (AZTREONAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC · version 4 · 2022-06-02
- AZTREONAM (AZTREONAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC · version 9 · 2022-04-12
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.